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Fig. 2.15 The Endolumik Fluorescence-Guided Gastric Calibration Tube after turning on NIR lighting system, white light view
D. Hui et al.
Fig. 2.16 The Endolumik Fluorescence-Guided Gastric Calibration Tube after turning on NIR lighting system, NIR light view
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calibration tube indicated for use in bariatric, gastric, and esopha­geal surgery to improve visualization of tube position and to serve as a sizing and measurement guide, for the application of suction, gastric decompression/drainage of gastric uids, and irrigation and leak testing [98]. This device combines the functionality of a nasogastric or orogastric tube, a calibration tube, and a leak test­ing system. The device was designed to improve intraoperative visualization and provide surgeons with additional visual cues to identify anatomic structures and delineate tissue planes with the goal of improving the precision of surgical dissection.
The Endolumik Gastric Calibration Tube is lit using NIR spec-
trum LEDs which enable transillumination through esophagogas­tric tissues. The tube is 80cm long and is available in two different diameters: 36 and 40 French. It has a rounded tip and small side holes at the distal end to enable gastric decompression and/or irri­gation. The proximal end includes a handle with an integral suc­tion regulator. An additional squeeze bulb with pressure gauge may be attached to the end of the regulator to perform leak testing. Pilot studies have been completed using the device to improve visualization during laparoscopic sleeve gastrectomy and laparo­scopic gastric bypass (Figs.2.17, 2.18, and 2.19). The three black stripes at the distal end of the device enable uorescence-guided measurement of up to 10cm of length (Fig.2.20).
Fig. 2.17 Use of the Endolumik Fluorescence-Guided Gastric Calibration Tube during gastric sleeve construction
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Fig. 2.18 Fluorescence-guided gastric sleeve construction during sleeve gastrectomy operation using the Endolumik calibration tube
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Fig. 2.19 Fluorescence-guided gastric pouch construction during gastric bypass operation using the Endolumik calibration tube
The device was FDA authorized on March 3, 2023, via the 510K pathway [99] and is also the first device to be authorized through the FDA Safer Technologies Program (STeP), a vol­untary program for medical devices that are reasonably expected to significantly improve the safety of currently avail­able treatments.
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Fig. 2.20 Use of the Endolumik Fluorescence-Guided Gastric Calibration Tube to make uorescence-guided measurements of gastric pouch length dur­ing gastric bypass
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Pearls and Pitfalls
• LED-powered NIR device obviates the need for ICG dye injec­tion.
• Compatible with all NIR surgical camera systems.
• Combines functionality of orogastric tube, calibration tube, and leak testing system.
• Provides uorescence-guided intraoperative visualization to enable more precise positioning and surgical dissection.
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