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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
100
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.
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Bellevue Hospital Center
New York, New York, United States
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
Time frame: 8 months
Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device
Time frame: 8 months
Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition
Time frame: 8 months
Additional procedure time needed to incorporate use of Napoleon
Time frame: 8 months
Proportion of cases with adverse events or unanticipated problems related to use of Napoleon
Time frame: 8 months
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