RecruitingNot Applicable

Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery

Mexico108 participantsStarted 2025-05-06

Plain-language 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 the optimal dose of this product for patients with obesity, so this study will aim to study if the dose in the minimal range recommended by international guidelines is sufficient for most patients or if higher doses are needed with increasing body mass index.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of obesity with a BMI ≥ 30 kg/m² * Scheduled for revisional bariatric surgery Exclusion Criteria: * 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).

What they're measuring

Time to Fluorescence Detection

Timeframe: Intraoperative (within 5 minutes post-injection)

Trial details

NCT IDNCT07000539

SponsorInstituto Mexicano del Seguro Social

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Obesity trials