Napoleon Measurement of Gastrojejunal Anastomosis

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 14, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Gastric BypassWeight Regain
Interventions
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.

Trial Locations (2)

10016

RECRUITING

Bellevue Hospital Center, New York

02115

RECRUITING

Brigham and Women's Hospital, Boston

All Listed Sponsors
collaborator

Brigham and Women's Hospital

OTHER

lead

NYU Langone Health

OTHER