Napoleon Measurement of Gastrojejunal Anastomosis

• Sponsor: NYU Langone Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04832282
• Collaborator: Brigham and Women's Hospital (Other)
• Enrollment: 100
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 24.5
• Patients Per Site: 50
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Bypass; Weight Regain	Device: Napoleon; Other: Visual estimation	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
• Actual Study Start Date: Jun 14, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation [8 months]

Secondary Outcome Measures

1. Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device [8 months]

2. Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition [8 months]

3. Additional procedure time needed to incorporate use of Napoleon [8 months]

4. Proportion of cases with adverse events or unanticipated problems related to use of Napoleon [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Bellevue Hospital Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04832282
• Other Study ID Numbers: 20-01436
• First Posted: Apr 5, 2021
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of May 13, 2022