Status:
RECRUITING
Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery
Lead Sponsor:
Instituto Mexicano del Seguro Social
Collaborating Sponsors:
Bariatric Medical Center
Conditions:
Obesity
Bariatric Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare different doses of a green fluorescent product that is administered during weight loss surgery in order to observe where blood vessels are located. There is uncertainty around ...
Eligibility Criteria
Inclusion
- Diagnosis of obesity with a BMI ≥ 30 kg/m²
- Scheduled for revisional bariatric surgery
Exclusion
- Allergy to iodides.
- Anticoagulation with products containing sodium bisulfite (due to the risk of ICG-FA inactivation).
- Use of radioactive iodine studies within the past 7 days.
- Pregnant, breastfeeding, or planning to become pregnant within the next year (due to unknown teratogenic or fertility effects of ICG-FA).
- History of liver disease or laboratory findings suggestive of moderate to severe hepatic disease: total bilirubin \>1.5 times the upper limit of normal (ULN), or any elevation of aspartate aminotransferase (AST) above ULN.
- Participants who withdraw their consent to participate in the study (elimination criterion).
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT07000539
Start Date
May 6 2025
End Date
February 28 2026
Last Update
June 3 2025
Active Locations (1)
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1
Centro Medico Bariatrico
Tijuana, Estado de Baja California, Mexico, 22046