Status:
ACTIVE_NOT_RECRUITING
The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Stryker Endoscopy
Conditions:
Ulcer, Gastric
Obesity, Morbid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y...
Detailed Description
The purpose of this study is to examine intraoperative usefulness of near-infrared light fluorescence imaging with a contrast agent called indocyanine green to improve visualization of blood flow to a...
Eligibility Criteria
Inclusion
- Capacity to provide informed consent.
- Over the Age of 18.
- Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB surgery by the bariatric program.
- Commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss.
- Treatment of marginal ulcer with the revisional surgery.
Exclusion
- Not willing to participate in study
- Contraindication to, or not planned to undergo RYGB
- Known allergy to indocyanine green or Sodium Iodide
- Is participant pregnant or planning to get pregnant in next two years
- Ongoing substance abuse or active smoking
- Bleeding diathesis or Coagulopathy
- Unwilling to take PPI medication Post operatively
Key Trial Info
Start Date :
January 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 3 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06002906
Start Date
January 25 2023
End Date
July 3 2027
Last Update
October 16 2025
Active Locations (1)
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1
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T2S8