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Search / Trial NCT07000539

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

Launched by INSTITUTO MEXICANO DEL SEGURO SOCIAL · May 24, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Bariatric Surgery Indocyanine Green Vascular Weight Loss Surgery Intraoperative Complications Postoperative Complications

ClinConnect Summary

This clinical trial is studying how different doses of a special green dye, called Indocyanine Green (ICG), can help doctors see blood vessels during weight loss surgery for patients with obesity. The goal is to find out if the lowest recommended dose of this dye is enough for most patients or if those with higher body weights need a larger dose. This is important because understanding the right dose can help improve the safety and effectiveness of the surgery.

To be eligible for the study, participants must have a body mass index (BMI) of 30 or higher and be scheduled for revisional bariatric surgery, which is a second surgery for weight loss. However, certain people cannot participate, including those who are allergic to iodides, pregnant or breastfeeding, or have specific liver conditions. If you join the study, you can expect to receive the dye during your surgery and help researchers gather valuable information that could benefit future patients. This trial is currently looking for participants, so it’s a good opportunity to contribute to important medical research.

Gender

ALL

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).

About Instituto Mexicano Del Seguro Social

The Instituto Mexicano del Seguro Social (IMSS) is a prominent public institution in Mexico, dedicated to providing comprehensive healthcare services and social security to its members. Established to enhance public health and welfare, IMSS plays a pivotal role in the advancement of medical research and clinical trials aimed at improving patient outcomes. By facilitating innovative studies, IMSS contributes to the development of new therapies and treatments, ensuring that the healthcare system remains at the forefront of scientific progress and responds effectively to the health needs of the population.

Locations

Tijuana, Baja California, Mexico

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported