Napoleon Measurement of Gastrojejunal Anastomosis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Bypass; Weight Regain
• Intervention / Treatment: Device: Napoleon; Other: Visual estimation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • New York, New York, United States, 10016
      • Bellevue Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Roux-en-Y gastric bypass patients with weight regain; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation	8 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20-01436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Violeta.Popov@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
• IPD Sharing Access Criteria: Requests may be directed to: Violeta.Popov@nyulangone.org.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes