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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Bariatric Surgery on Cardiovascular Risk Profile in Relation to Inflammatory Parameters: Endothelial Phenotyping and Analysis of the Cross-talk Between Adipose Tissue and Endothelium

NCT07131605

Obesity (Disorder)

RECRUITING NA

Biomarkers Derived From Adipose Tissue Useful for Diagnosis and Prognosis of Cardiovascular Risk (CVR) in Obese Patient

NCT03561987

Metabolic Syndrome Diabetes Mellitus Inflammatory Response

UNKNOWN

Bariatric Surgery and the Kidney

NCT01410994

Proteinuria

COMPLETED

Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery

NCT04683666

Complication of Surgical Procedure

COMPLETED

Iron Metabolism in Obesity

NCT07157332

Obesity (Disorder)

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Bariatric Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Group assignment is centrally managed. Participants are blinded under anesthesia, with no awareness of group assignment. The anesthesiologist knows the dose but is blinded to outcomes and conceals the dose from surgeons. Data collectors and laboratory technicians are not informed of group assignment or study purpose. Adjudicators of outcomes, not involved in surgery, will assess postoperative videos blinded to patient characteristics and knowing only the timing of drug administration. Data analysts and the data safety monitoring committee use coded identifiers to remain blinded to group assignments. The manuscript's results will be written blinded, after which codes will be replaced for actual doses to interpret and discuss the findings.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

indocyanine green (5 mg)

Participants in this arm will receive a single 5 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care.

Group Type ACTIVE_COMPARATOR

Indocyanine Green Angiogram

Intervention Type DIAGNOSTIC_TEST

Three different doses of indocyanin green will be compared (5 mg, 7.5 mg, and 10 mg). These doses are within the range of currently recommended doses by the International Society for Fluorescence Guided Surgery (ISFGS) for bariatric surgery.

indocyanine green (7.5 mg)

Participants in this arm will receive a single 7.5 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care.

Group Type ACTIVE_COMPARATOR

Indocyanine Green Angiogram

Intervention Type DIAGNOSTIC_TEST

Three different doses of indocyanin green will be compared (5 mg, 7.5 mg, and 10 mg). These doses are within the range of currently recommended doses by the International Society for Fluorescence Guided Surgery (ISFGS) for bariatric surgery.

indocyanine green (10 mg)

Participants in this arm will receive a single 10 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care.

Group Type ACTIVE_COMPARATOR

Indocyanine Green Angiogram

Intervention Type DIAGNOSTIC_TEST

Three different doses of indocyanin green will be compared (5 mg, 7.5 mg, and 10 mg). These doses are within the range of currently recommended doses by the International Society for Fluorescence Guided Surgery (ISFGS) for bariatric surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indocyanine Green Angiogram

Three different doses of indocyanin green will be compared (5 mg, 7.5 mg, and 10 mg). These doses are within the range of currently recommended doses by the International Society for Fluorescence Guided Surgery (ISFGS) for bariatric surgery.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ICG-FA Indocyanine green fluorescence angiography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No