NCT04832282

Napoleon Measurement of Gastrojejunal Anastomosis

Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Bypass
• Weight Regain

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Visual estimation	For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.

Timeline

• Start date: 2021-06-14
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2021-04-05
• Last updated: 2025-12-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study