Napoleon Measurement of Gastrojejunal Anastomosis

NYU Langone Health

Status and phase: Enrolling; Early Phase 1

Conditions: Gastric Bypass; Weight Regain

Treatments: Other: Visual estimation; Device: Napoleon

Study type: Interventional

Funder types: Other

Identifiers

NCT04832282

20-01436

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Roux-en-Y gastric bypass patients with weight regain

Other group

Description:

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.

Treatment:

Device: Napoleon

Other: Visual estimation