Napoleon Measurement of Gastrojejunal Anastomosis
Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Start
First participant enrolled
June 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedDecember 23, 2025
December 1, 2025
4 years
April 1, 2021
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
8 months
Secondary Outcomes (4)
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
Study Arms (1)
Roux-en-Y gastric bypass patients with weight regain
OTHERThe 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.
Interventions
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
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.
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- RYGB patient with weight regain age 18-90
- Scheduled for an endoscopy
- Willingness and ability to provide informed consent
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- \. History of prior endoscopies with complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitalcollaborator
- NYU Langone Healthlead
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Bellevue Hospital Center
New York, New York, 10016, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 5, 2021
Study Start
June 14, 2021
Primary Completion
June 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
- Access Criteria
- Requests may be directed to: Violeta.Popov@nyulangone.org.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Violeta.Popov@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.