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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Mexicano del Seguro Social

About this trial

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

Qualifiers

Diagnosis of obesity with a BMI ≥ 30 kg/m²

Scheduled for revisional bariatric surgery

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Indocyanine Green Angiogram

Treatment groups

108 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Instituto Mexicano del Seguro Social

Lead sponsor

Bariatric Medical Center

Collaborator