RECRUITING

Napoleon Measurement of Gastrojejunal Anastomosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-06-14
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04832282

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. RYGB patient with weight regain age 18-90
  2. 2. Scheduled for an endoscopy
  3. 3. Willingness and ability to provide informed consent
  1. 1. History of prior endoscopies with complications

Contacts and Locations

Study Contact

Violeta Popov, MD
CONTACT
212-686-7500
Violeta.Popov@nyulangone.org
Sandy Ng, MD
CONTACT
Sandy.Ng@nyulangone.org

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Bellevue Hospital Center
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-14
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-06-14
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Gastric Bypass
  • Weight Regain