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

RecruitingNAAges 18 Years - anyAllInstituto Mexicano del Seguro Social
NCT07000539 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Indocyanine Green Angiogram
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Where

1 site
Centro Medico Bariatrico
Tijuana, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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