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Napoleon Measurement for Gastric Bypass Evaluation

Phase < 1

Recruiting

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willingness and ability to provide informed consent

Be older than 18 years old

Must not have

History of prior endoscopies with complications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is measuring the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). Up to 100 cases will be looked at. The Napoleon device will be used to measure the GJA and then compared to visual estimation. A survey will be given to assess the level of ease using Napoleon.

Who is the study for?

This trial is for Roux-en-Y gastric bypass patients aged 18-90 who have experienced weight regain and are scheduled for an endoscopy. They must be willing to consent to the study. Those with a history of complications from prior endoscopies cannot participate.

What is being tested?

The Napoleon device's ability to measure the size of gastrojejunal anastomosis in gastric bypass patients is being tested against traditional visual estimation by doctors during endoscopy procedures at two hospitals.

What are the potential side effects?

Since this trial involves measurement techniques rather than medication, typical drug side effects are not expected. However, risks may include those generally associated with undergoing an endoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to give my consent for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had complications from previous endoscopies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Roux-en-Y gastric bypass patients with weight regainExperimental Treatment2 Interventions

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.

0 / 2Eligibility criteria met