Gastric Bypass, Weight Regain
Conditions
Brief summary
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.
Interventions
DEVICENapoleon
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.
OTHERVisual estimation
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
Sponsors
Brigham and Women's Hospital
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device | 8 months |
| Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition | 8 months |
| Additional procedure time needed to incorporate use of Napoleon | 8 months |
| Proportion of cases with adverse events or unanticipated problems related to use of Napoleon | 8 months |
Countries
United States
Outcome results
None listed