Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery
Recruiting · NCT07000539 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto Mexicano del Seguro Social
View the official record on ClinicalTrials.gov →Interventions studied
Indocyanine Green Angiogram
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Centro Medico Bariatrico - Tijuana, Estado de Baja California, Mexico