Napoleon Measurement of Gastrojejunal Anastomosis

Running, not enrolling · Not applicable

Conditions studied: Gastric Bypass, Weight Regain

In brief

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.

Key facts

Study ID

NCT04832282

Run by

NYU Langone Health

People needed

100

Starts

2021-06-14

Expected to finish

2026-06-30

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• RYGB patient with weight regain age 18-90
• Scheduled for an endoscopy
• Willingness and ability to provide informed consent

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• History of prior endoscopies with complications

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Bellevue Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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