Using indocyanine green to map blood flow during revisional bariatric surgery
Official title: Prospective Single-center Diagnostic Parallel-group Study to Determine the Minimal Dose of Indocyanine Green to Observe Vascular Perfussion in Revisional Bariatric Surgery.
Run by Instituto Mexicano del Seguro Social · NCT07000539 · Data updated 2026-11-12
This test will see if the low guideline dose of indocyanine green or a higher dose gives clearer blood-vessel imaging during revisional bariatric surgery for people with BMI ≥30.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Tijuana, Estado de Baja California) |
| Status | Recruiting |
| Started | May 6, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07000539 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with obesity (BMI ≥30) who are scheduled for revisional bariatric surgery and who do not have iodine allergy, significant liver disease, pregnancy, recent radioactive iodine exposure, or contraindicated anticoagulation are the intended participants.
✕Probably not a fit
People with iodine allergy, moderate-to-severe hepatic dysfunction, recent radioactive iodine studies, those who are pregnant or breastfeeding, or on contraindicated anticoagulation are excluded and would not benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients scheduled for revisional bariatric surgery with BMI ≥30 will receive intraoperative indocyanine green at predefined dose levels and undergo fluorescence angiography to visualize vascular perfusion. The study will compare image quality, vessel visibility, and any dose-related adverse events across a range of BMIs to determine whether the minimal recommended dose is sufficient or higher doses are needed. Imaging and safety data will be collected during surgery and recorded by the surgical team according to the study protocol. Results will be analyzed to identify dose-response patterns and inform dosing recommendations for obese patients undergoing revisional procedures.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the safest effective ICG dose, improving vessel visualization and potentially reducing intraoperative complications.
How similar studies have gone: ICG fluorescence angiography is widely used and has supported better perfusion assessment in bariatric and other gastrointestinal surgeries, but specific dose-optimization studies for obese patients in revisional bariatric surgery are limited.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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Centro Medico Bariatrico
Tijuana, Estado de Baja California, Mexico Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.