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.
Source : Importé depuis le centre
RECRUTEMENT
Profil des participants
Limites d'âge
minimum : 18 ans
maximum : 90 ans
Sexe(s) des participants
ALL
Source : Importé depuis le centre
Condition médicale (spécialité visée)
Domaine de recherche
Donnée non disponible
Critères de sélection
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Roux-en-Y gastric bypass patients with weight regain
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.
Donnée non disponible
Inconnu
Roux-en-Y gastric bypass patients with weight regain
État du recrutement
unknown
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.
Données à jour depuis :
16 décembre 2025
SITES ET CONTACTS
Centre principal
brigham and women's hospital
BOSTON, MASSACHUSETTS, UNITED STATES
Recrutement local
—
FERMÉ
Dernière modification :
16 décembre 2025
Données à jour depuis :
18 déc.
Origine des données :
clinicaltrials.gov
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
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Roux-en-Y gastric bypass patients with weight regain
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.
Donnée non disponible
Inconnu
Roux-en-Y gastric bypass patients with weight regain
État du recrutement
unknown
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.
Données à jour depuis :
16 décembre 2025
Description de l'étude
Description de l'étude
Résumé de l'étude
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.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
1
centres
BRIGHAM AND WOMEN'S HOSPITAL
Boston
MASSACHUSETTS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Source d'information
Dernière modification :
16 décembre 2025
Données à jour depuis :
18 déc.
Origine des données :
clinicaltrials.gov