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(<1 cm), nonbleeding ulcer was observed during
the endoscopy to remove balloons at the end of
the treatment period and was reported as possibly
related to the contraindicated use of NSAIDs.
Finally, one esophageal laceration (0.8%) was
observed after balloon removal in a patient
diagnosed with eosinophilic esophagitis. While
the device is currently not FDA-approved, the
US Pivotal Trial for the Obalon IGB has been
under way with published results awaiting
release.
Elipse Gastric Balloon
The Elipse™ balloon (Allurion Technologies,
Wellesley, MA) is another example of an intra-
gastric balloon. While an IGB is technically not
an EBT, as novel technology is utilized elimi-
nating endoscopy and sedation for both implan-
tation and removal, these devices should be
included under nonsurgical approaches to pro-
cedural management of obesity. The Elipse is
enclosed inside a capsule and is attached to a
thin, flexible catheter long enough to remain
outside the patient’s mouth once the capsule is
swallowed (Fig. 10.3). Once in the stomach the
capsule quickly dissolves, the balloon is filled
with 550 mL of fluid. When filling is complete,
the detachable catheter is removed. The Elipse
balloon is designed to remain within the stomach
for a predetermined period of several months, at
which point a valve opens based on timed-release
technology, allowing the balloon to empty
automatically from the stomach and be excreted
spontaneously from the GI tract. In a
proof-of-concept pilot study, 8 patients swal-
lowed a smaller prototype Elipse balloon inten-
ded to remain in the stomach for 6 weeks,
self-empty, and then pass [65]. There were no
serious adverse events, and all balloons were
swallowed as well as excreted safely. Despite not
being prescribed a diet or exercise plan, all eight
patients lost weight, and after 6 weeks of Elipse
therapy, the mean weight loss was 2.4 kg and
mean %EWL was 12.4%. In results presented at
the 2015 Obesity Week conference and submit-
ted for publication, a larger study of 34 individ-
uals with BMI between 27 and 40 found an
average weight loss of 10 kg (22 lb), 39% EWL,
10% TWL, and 8 cm off their waist circumfer-
ence over the 4-month treatment period, with
improvements in triglycerides, hemoglobin A1c,
and quality of life. All balloons were safely and
naturally excreted. In 2015, the device received
European Marketing Approval and is in the
Fig. 10.3 Elipse™
intragastric balloon
(Courtesy of Allurion
Technologies)
130 J. Cohen and R. Chuttani
planning phases for a US Pivotal Trial-seeking
FDA approval.
Spatz3 Adjustable Balloon System®
The Spatz3 Adjustable Balloon System
®
(Spatz
Medical, Great Neck, NY) is an endoscopically
placed IGB that is filled with saline. It has an
extractable inflation tube allowing for variable
volume adjustment while the balloon remains in
the stomach. Balloon volume may be increased to
enhance the efficacy or decreased to improve the
patient tolerance and is approved for 12-month
implantation outside of the USA. Regarding effi-
cacy data, two small observational studies evalu-
ated weight-loss outcomes after Spatz3 Adjustable
Balloon
®
deployment in 94 obese patients. At
12 months, when the balloon was removed, %
EWL was 46% [66, 67]. Finally, a case–control
study comparing Spatz3
®
to Orbera™ balloons
found no difference in weight-loss outcomes at
12 months. The study evaluated 80 patients who
had sequential placement of two Orbera balloons
(6 months each) to 40 patients with the Spatz3
adjustable balloon for 12 months; however, 15%
of the Spatz devices were removed due to com-
plications related to device hardware and migra-
tion [68]. Newer versions of the Spatz3 balloon are
addressing these engineering challenges.
Restrictive Procedu res and Devices
Restrictive procedures remodel the stomach via
stapling, suturing, or tissue anchor placement to
reduce gastric volume and achieve effects anal-
ogous to gastric pouch formation as in the
Roux-en-Y gastric bypass or sleeve gastrectomy.
OverStitch™ for Endoscopic Sleeve
Gastroplasty
Endoscopic sleeve gastroplasty (ESG) is a tran-
soral endoscopic gastric volume reduction proce-
dure that reduces gastric capacity in a similar
fashion to sleeve gastrectomy without the need for
gastric surgery. The Apollo OverStitch™ device
(Apollo Endosurgery, Austin, TX), which is FDA-
approved, allows placement of full-thickness
sutures in a variety of interrupted or running pat-
terns using a double-channel therapeutic gastro-
scope (Fig. 10.4a). ESG is accomplished by
placing these full-thicknes s sutures through the
gastric wall utilizing a tissue helix device to cap-
ture tissue extending from the prepyloric antrum to
the gastroesophageal junction reducing the entire
stomach along the greater curvature (Fig. 10.4b).
Increasing data have been published showing the
safety and efficacy of ESG. A 20-subject trial from
Spain, in subjects with a mean basel ine BMI of
38.5 kg/m
2
, demonstrated a mean body weight
reduction of 19.3 ± 8.9 kg at 6 months (17.8%
TWL). In a New York study, ESG was performed
on 10 subjects with a mean BMI of 45.2 kg/m
2
and
reported no significant adverse events [69]. After
1 month, 3 months, and 6 months, excess weight
loss of 18, 26, and 30% and mean weight loss of
11.5, 19.4, and 33.0 kg, respectively, were
observed. In a 1-year follow-up study from Spain
with 25 patients, there were no major intraproce-
dural, early, or delayed adverse events from ESG,
and mean %TWL was 18.7 ± 10.7 at 1 year. In
regression analysis, predictors of successful
weight loss were the number of nutritional and
psychological contacts each patient had. Notably,
at 1-year follow-up, only one patient underwent a
revision partial gastroplasty because of loosened
applications, demonstrating significant durability
of ESG suture lines. Finally, a Mayo Clinic series
of 25 patients with mean BMI of
35.5 ± 2.6 kg/m
2
has been released [70]. After 6,
9, 12, and 20 months, subjects had lost 53 ± 17%,
56 ± 23%, 54 ± 40%, and 45 ± 41% of excess
body weight, respectively, after the procedure.
Endoscopy at 3 months showed intact gastro-
plasty in all subjects. Physiological analyses of 4
patients showed that ESG delays gastric emptying
and induces early satiety. Finally, 3 subjects had
serious adverse events (a perigastric inflammatory
collection, a pulmonary embolism, and a small
pneumothorax) but made full recoveries without
surgical intervention.
10 Endoluminal Bariatric Procedures 131
Fig. 10.4 a and b OverStitch™ for endoscopic sleeve gastroplasty (Courtesy of Apollo Endosurgery)
132 J. Cohen and R. Chuttani
These studies suggest that ESG is a promising
procedure for significant weight loss in patients
seeking endoscopic alternatives to sleeve gas-
trectomy. However, more data are needed to
evaluate long-term durability and safety of the
endoscopic gastroplasty procedure. As with any
stomach-excluding procedure, the risk of disease
such as ulcers or gastric cancer in the remnant
stomach remains. The Primary Obesity Multi-
center Incisionless Suturing Evaluation (PRO-
MISE) trial (NCT01662024) to study efficacy of
ESG using OverStitch™ has been completed in
the USA, but the results are not yet available.
Finally, as with other EBTs, USA insurance
companies do not yet cover this procedure, and
thus, costs can be significant to the patient.
Incisionless Operating Platform
for Primary Obesity Surgery
Endoluminal (POSE)
The incisionless operating platform (IOP) used to
perform the primary obesity surgery endoluminal
(POSE) procedure uses a per-oral incisionless
operating platform (USGI Medical, San Cle-
mente, CA) to place 8–10, full-thickness, tissue
anchor applications that reduce accommodation
of the gastric fundus. Several applications are
also placed in the distal gastric body to delay
gastric emptying (Fig. 10.5a, b). The large
overtube-style platform of the IOP is the Trans-
Port
®
, which is steerable in 4 directions, with 4
working channels that accommodate a slim
4.9-mm endoscope and 3 specialized instru-
ments. These include the g-Prox
®
,aflexible
endoscopic grasper with a jawed gripper for
creating serosa-to-serosa tissue folds and able to
cut suture, the g-Lix™,aflexible tissue grasper
with a distal helical tip designed to assist the
g-Prox
®
in captur ing target tissue for a
full-thickness plication, and the g-Cath™,
a suture–anchor delivery catheter system with a
needle at its distal tip that, after advancement
through the lumen of the g-Prox
®
, penetrates the
target tissue deploying a pair of preloaded tissue
anchors joined by suture material which holds
the plication until serosal fusion occurs.
A single-center, open-label, prospective trial
from Spain enrolling 45 obese patients with
mean BMI of 36.7 kg/m
2
demonstrated the fea-
sibility and safety of the POSE procedure [71].
At 6 months, BMI decreased by 5.8 kg/m
2
,
%EWL was 49.4%, and %TWL was 15.5%
without any operative morbidity or mortality.
Subjects reported less hunger and earlier satiety
post-procedure. Liquid intake began 12 h
post-procedure, with full solids by 6 weeks.
The ESSENTIAL Trial (NCT01958385) is a US
multicenter, randomized, sham-controlled, piv-
otal trial of the POSE procedure which has
enrolled 332 subjects for goal follow-up of
12 months to evaluate safety and efficacy
Fig. 10.5 a and b Incisionless operating platform for
primary obesity surgery endoluminal (POSE) procedure
(Courtesy of USGI Medical)
10 Endoluminal Bariatric Procedures 133
endpoints. Results of this trial are expected to be
released shortly.
Small-Bowel Bypass Devices
and Procedures
The proximal small bowel actively manages
nutrient absorption and thus is believed to sig-
nificantly mediate glucose homeostasis and play
a role in the pathogenesis of diet-induced dia-
betes. Thus, bypass of the proximal small intes-
tine is believed to contribute importantly to the
weight loss and metabolic benefits experienced
after certain bariatric surgeries. This rationale is
supported by human and animal research evalu-
ating duodenal exclusion [72–74]. EBTs have
been developed and studied with hopes of
reproducing this effect.
EndoBarrier® Duodenal-Jejunal Bypass
Liner
The EndoBarrier
®
(GI Dynamics, Lexington,
MA) is a duodenojejunal bypass sleeve (DJBS)
consisting an impermeable sleeve of Teflon
anchored in the bulb of the duodenum by a
nitinol crown with barbs. The 65-cm sleeve and
anchoring device are restrained within a delivery
capsule that is advanced to the duodenal bulb
over a stiff wire under e ndoscopic and fluoro-
scopic guidance and subsequently deployed. The
sleeve extends into the jejunum and prevents
food contents from contacting the mucosa of the
proximal small intestine, allowing food to reach
the mid-jejunum earlier. However, the sleeve
allows pancreaticobiliary secretions to move
along the outside of the device to the jejunum.
The EndoBarrier
®
is removed endoscopically
after 12 months via a custom device retrieval
hood to help avoid trauma to the stomach or
esophagus upon explantation. Out of seven
studies involving EndoBarrier, the %EWL ran-
ged between 12% and 22% at 12 weeks, 24 and
32% at 24 weeks, and 30 and 47% at 52 weeks
[75–81]. A meta-analysis of four RCTs from
these studies compared 12–24 weeks of
treatment with the EndoBarrier
®
DJBS (90
patients) with a sham or control arm (84
patients). The mean %EWL difference compared
with a control group was significant at 9.4%
(95% CI, 8.26–10.65) [46]. Improvement in %
hemoglobin A1c was significant compared with
sham or control diabetic group, where the
EndoBarrier
®
DJBS resulted in an additional 1%
reduction compared to controls [46]. Regarding
the safety profile of the EndoBarrier
®
, this same
meta-analysis reviewed the 271 implantations in
the literature and found a pooled early device
removal rate of 18.4%. Seriou s adverse events
included migration (4.9%), GI bleeding (3.86%),
sleeve obstruction (3.4%), liver abscess
(0.126%), cholangitis (0.126%), acute cholecys-
titis (0.126%), and esophageal perforation
(0.126%) secondary to trauma from an uncov-
ered barb at withdrawal. Notably, the multicenter
US Pivotal ENDO Trial (NCT01728116) was
placed on hold in March 2015 by the FDA after
reports of 7 cases of hepatic abscess among the
325 patients already enrolled of the 500 initial
sample size. Thus, the future clinical use of
EndoBarrier in the USA is uncertain.
Other endoscopic bypass devices such as the
gastroduodenojejunal bypass sleeve (ValenTx,
Inc., Hopkins, MN) is a 120-cm long fluoropoly-
mer sleeve that is secured at the gastroesophageal
junction. It remains under investigational
development.
Aspiration Therapy
Aspiration therapy is a novel therapeutic approach
for weight loss that allows obese patients to dis-
pose a significant portion of their ingested caloric
intake via a specially designed percutaneous
endoscopic gastrostomy (PEG) tube.
AspireAssist®
The AspireAssist
®
(Aspire Bariatrics, King of
Prussia, PA) is a modified PEG tube with an
external accessory for aspirating about one-third
of the ingested meal ideally 20 min after
134 J. Cohen and R. Chuttani
consumption and takes about 5–10 min to com-
plete (Fig. 10.6). The device includes a large-bore
fenestrated silicone gastrostomy tube (A-Tube)
which is attached to a skin port with a connector
and valve placed at the skin. A 600-mL reservoir
facilitates flushing and aspiration of gastric con-
tents postprandially. A randomized, pilot,
proof-of-concept study published by Sullivan et al.
in 2013 studied 18 subjects with 11 assigned to
AspireAssist
®
and 7 to the control group [82]. All
patients underwent a 15-session diet and behav-
ioral education program. Ten of the 11 subjects in
the aspiration therapy group and 4 of the 7 subjects
in the lifestyle therapy group completed the first
year of the trial. After 12 months, the aspiration
therapy group achieved TWL of 18.6% and EWL
of 49.0% compared to 5.9% TWL and 14.9%
EWL in the lifestyle therapy control arm. Seven of
the 10 subjects in the AspireAssist
®
group decided
to complete an additional 12 months of therapy
and maintained a 20.1% TWL with 54.6% EWL.
Notably, there was no evidence of binge eating
behavior in the aspiration therapy group, nor evi-
dence of increased food intake to compensate for
aspirated food. Reported adverse events included
abdominal pain at the PEG tube site, site infection
in 3 patients, and persistent gastrocutaneous fis-
tula, which eventually closed spontaneously, in 1
patient. A more recent study from Sweden evalu-
ated 25 obese patients with mean BMI of
39.8 ± 0.9 kg/m
2
and found that after 6 months,
mean weight lost was 16.5 kg and %EWL was
40.8 in the 22 subje cts who completed 26 weeks of
therapy. Two patients were hospitalized for
adverse events including 1 subject for pain after
PEG tube placement and another due to an aseptic
intra-abdominal fluid collection 1 day after gas-
trostomy tube placement. Notably, there were no
clinically significant changes in electrolytes.
While aspiration therapy is an interesting and
promising approach with preliminary results
demonstrating high efficacy and safety, more
long-term data will be needed given concern for
possibly inducing eating disorders. The Pivotal
Fig. 10.6 AspireAssist
®
10 Endoluminal Bariatric Procedures 135
Aspiration Therapy With Adjusted Lifestyle
Therapy Study (PATHWAY) prospective multi-
center clinical trial in the USA is currently under
way (NCT01766037).
Other Novel Endoscopic Bariatric
Therapies
Revita™ Duodenal Mucosal
Resurfacing (Fractyl Laboratories)
As previously mentioned, given that the proxi-
mal small intestine plays an extremely active role
in glucose homeostasis, research has indicated
that the duodenum may play a significant role in
the pathogenesis of diet-induced diabetes [72,
73]. Enteroendocrine cells in the duodenum
sense luminal nutrients and release gut peptides
that are thought to mediate satiety and enhance
insulin secretion [incretins, including gastric
inhibitory polypeptide (GIP) and glucag on-like
peptide-1 (GLP-1)] which may account for the
fact that oral glucose administration promotes a
much greater degree of insulin secretion com-
pared to a parenteral glucose infusion (incretin
effect) [83]. However, it is unclear whether a
reduced incretin effect in type 2 diabetes is a
cause or consequence of the diabetic state [84].
In the Revita™ Duodenal Mucosal Resurfacing
(DMR) procedure (Fractyl Laboratories, Cam-
bridge, MA), thermal ablation of the superficial
duodenal mucosa is performed using radiofre-
quency energy after lifting it with a submucosal
saline injection (Fig. 10.7a, b). It is believed that
this procedure may result in mucosal remodeling
and hypothetically reset duodenal enteroen-
docrine cells that have become diseased, thus
restoring signaling that can improve diabetic
control potentially through an incretin effect.
Clinical investigations are underway.
Self-assembling Magnets
for Endoscopy (GI Windows)
Self-assembling magnets for endoscopy (GI
Windows, Boston, Mass) is a novel technology
that generates incisionless magnetic compression
anastomoses such as gastrojejunostomies, gas-
troileostomies, and duodenoileostomies [85].
This small-bowel malabsorptive procedure is
intended to promote weight loss and improve-
ment in diabetes via the ileal break phenomenon
whereby infusion of nutrients and bile directly
into the distal part of the small intestine alters
gastrointestinal motility and inhibits food intake
[86]. A recent 3-month porcine survival study
evaluating 8 animals showed that large-caliber,
leak-free, foreign-body-free, endoscopic intesti-
nal bypass by using Incisionless Anastomosis
System [IAS]. Magnets could be safely and
rapidly performed using only intravenous seda-
tion [87]. The mean 3-month weight gain was
45 kg in bypass pigs and 78 kg in controls
(P = 0.01). Additional clinical trials are under
way to evaluate the safety and efficacy of this
device.
Future Frontiers in Endoluminal
Bariatrics
With the armamentarium of endoluminal bar-
iatric therapies growing each year and several
devices awaiting FDA approval on the near
horizon line, the bariatric endoscopist will have
an increasing number of treatment options
available to offer patients. Along these lines,
there are several key elements which we feel may
greatly shape the field of bariatric endoscopy in
the future.
Novel Professional Collaborations
and Personalized Endobariatrics
With the range of devices to treat obesity, as well
as those targeting metabolic disease such as
diabetes exclusively, new practice patterns will
need to evolve as part of multidisciplinary expert
teams for patients. One example of this is that
endocrinologists at present do not refer patients
directly to gastroenterologists for management of
diabetes. But by generating increased awareness
of EBTs as well as forming comprehensive
136 J. Cohen and R. Chuttani
weight centers designed to ensure expert patient
selection and close follow-up for patients, such
practice patterns may change. Full-service weight
centers with collaborative input from gastroen-
terology, bariatric surgery, endocrinology, hepa-
tology, psychology, exercise physiology,
nutrition support, and internal medicine will be
crucial to ensuring the best possible results for
each individual patient. Along these lines, with
the large number of EBTs which will likely be
available, personalizing the right treatment for
each patient will require significant expertise in a
Fig. 10.7 a and
b Revita™ duodenal
mucosal resurfacing
(Courtesy of Fractyl
Laboratories)
10 Endoluminal Bariatric Procedures 137
range of therapeutic options. Additionally, as
better understanding behind the pathophysiology
of each patient’s obesity arises, we may be better
equipped to target and individualize these thera-
pies based on rational hypotheses. With the aid
of team collaborations, bariatric endoscopists
will need to create pathways of preprocedural,
intraprocedural, and post-procedural care which
may be unique to their previous work, including
design of clinics and endoscopy suites for bar-
iatric patients, as well as addressing best prac-
tices in venous thromboembolism prophylaxis.
Combination of Endoscopic
and Adjunctive Medical Bariatric
Therapies
With EBTs in development that deconstruct the
various components of gold-standard bariatric
surgical interventions such as the Roux-en-Y
gastric bypass, combination therapies which tar-
get multimodal elements of surgical weight loss
will likely be deployed. Rational combinations of
EBTs such as joining IGB or ESG with endo-
scopic bypass technology or Revita™ dudoenal
mucosal resurfacing have the potential to
increase the levels of weight loss to those
achieved with higher-morbidity bariatric surg-
eries. Such combination therapies will need to
undergo rigorous safety and efficacy trials similar
to the single-device studies previously done.
Finally, more repeatability trials, which study the
results of multiple sequential therapies such as
repeat IGBs, will be important [88]. Just as
combination of EBTs will likely arise, adjunctive
therapies combining medications for weight-loss
maintenance hold promise.
Comparative and Cost Effectiveness
Research
As the bariatric surgery literature is replete with
long-term data demonstrating favorable effects
on reducing morbidity and mortality from obe-
sity and metabolic disease, endoluminal bariatric
therapies will need to be studied with similar
rigor. Primary endpoints related to weight loss
are necessary but not sufficient, as increased
pressures to contain costs and promote compar-
ative effectiveness research increase. To do this,
it will be essential to establish national and
international registries of patients which can
track outcomes related to safety and efficacy.
Given the apparent safety of the less invasive
endoscopic methods, head-to-head trials between
endoluminal and surgical bariatric procedures
may not be necessary for complimentary
technologies.
Reimbursement and Insurance
Coverage
For EBTs to effectively bridge the gap between
medical weight loss and bariatric surgery, insur-
ance approval for these devices and procedures
will be needed to expand the pool of candidate
patients. At present, these devices in the USA are
paid for out of pocket, limiting their use to
patients with significant financial means.
Governing bodies such as the American Society
for Gastrointestinal Endoscopy (ASGE), the
American Society for Metabolic and Bariatric
Surgery (ASMBS), and Association for Bariatric
Endoscopy (ABE) will likely play integral roles
in dialogues between large insurers and patients
requesting the devices.
Frameshift for a Healthier World
Finally, as we move from a reactive to proactive
healthcare paradigm, a frameshift in our
approach to obesity and obesity-related diseases
must target prevention strategies. Thus, future
trials with EBTs targeting BMI in the overweight
category will be important toward this end given
that by the time class I obesity begins, reversing
pathophysiologic processes and behaviors likely
becomes more challenging than early interven-
tion. Endoluminal bariatric therapies hold great
promise to improve worldwide health, and the
bariatric endoscopist is poised to play a critical
role in this positive change.
138 J. Cohen and R. Chuttani
Disclosures Jonah Cohen has no disclosures to report
related to this work.
Ram Chuttani is a senior medical advisor to Allurion
Technologies.
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