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Clinical Trial Summary

This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04832282
Study type Interventional
Source NYU Langone Health
Contact Violeta Popov, MD
Phone 212-686-7500
Email Violeta.Popov@nyulangone.org
Status Recruiting
Phase Early Phase 1
Start date June 14, 2021
Completion date June 30, 2025

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