NCT07000539 Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery
| NCT ID | NCT07000539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Mexicano del Seguro Social |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2025-05-06 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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).
Frequently Asked Questions
Who can join the NCT07000539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07000539 currently recruiting?
Yes, NCT07000539 is actively recruiting participants. Visit ClinicalTrials.gov or contact Instituto Mexicano del Seguro Social to inquire about joining.
Where is the NCT07000539 trial being conducted?
This trial is being conducted at Tijuana, Mexico.
Who is sponsoring the NCT07000539 clinical trial?
NCT07000539 is sponsored by Instituto Mexicano del Seguro Social. The trial plans to enroll 108 participants.
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