Study Summary
This trial is measuring the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). Up to 100 cases will be looked at. The Napoleon device will be used to measure the GJA and then compared to visual estimation. A survey will be given to assess the level of ease using Napoleon.
Eligible Conditions
- Gastric Bypass
- Weight Gain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 8 months
8 months
Additional procedure time needed to incorporate use of Napoleon
Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
Proportion of cases with adverse events or unanticipated problems related to use of Napoleon
Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device
Trial Safety
Trial Design
0 Treatment Group
100 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase < 1
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months
Who is running the clinical trial?
Brigham and Women's HospitalOTHER
1,480 Previous Clinical Trials
9,735,681 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,264 Previous Clinical Trials
753,491 Total Patients Enrolled
Eligibility Criteria
Age 18 - 90 · All Participants · 3 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments