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Napoleon Measurement of Gastrojejunal Anastomosis
Sponsor: NYU Langone Health
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.
Official title: Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-06-14
Completion Date
2026-06-30
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
Napoleon
The Micro-Tech Endoscopic Measurement Device named Napoleon is a small catheter with a 30mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA. The device was originally intended to measure polyps. However, it is used off-label in this study and is considered investigational.
Visual estimation
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
Locations (2)
Brigham and Women's Hospital
Boston, Massachusetts, United States
Bellevue Hospital Center
New York, New York, United States