Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2021-06-14
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
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.
Visual estimation
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
Interventions
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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.
Visual estimation
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
Eligibility Criteria
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Inclusion 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
1\. History of prior endoscopies with complications
18 Years
90 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
NYU Langone Health
OTHER
Responsible Party
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Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Bellevue Hospital Center
New York, New York, United States
Countries
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Other Identifiers
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20-01436
Identifier Type: -
Identifier Source: org_study_id