Napoleon Measurement of Gastrojejunal Anastomosis

Early Phase 1

Recruiting

• Conditions: Gastric Bypass; Weight Regain
• Interventions: Device: Napoleon; Other: Visual estimation

• Registration Number: NCT04832282
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Study Start: 2021-06-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. RYGB patient with weight regain age 18-90
2. Scheduled for an endoscopy
3. Willingness and ability to provide informed consent

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. History of prior endoscopies with complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Roux-en-Y gastric bypass patients with weight regain	Visual estimation	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.
Roux-en-Y gastric bypass patients with weight regain	Napoleon	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.

Primary Outcome Measures

Name	Time	Method
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation	8 months

Secondary Outcome Measures

Name	Time	Method
Additional procedure time needed to incorporate use of Napoleon	8 months
Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition	8 months
Proportion of cases with adverse events or unanticipated problems related to use of Napoleon	8 months
Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device	8 months

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Bellevue Hospital Center; 🇺🇸 New York, New York, United States