Napoleon Measurement of Gastrojejunal Anastomosis

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

Conditions
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Gastric Bypass, Weight Regain

Intervention / Treatment
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* Device: Napoleon
* Other: Visual estimation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: RYGB patient with weight regain age 18-90 Scheduled for an endoscopy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Roux-en-Y gastric bypass patients with weight regain<br>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<br>* 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.<br>Other: Visual estimation<br>* For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |