[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592984":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":31,"locations":32,"responsibleParty":53,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":31,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"indocyanine green (5 mg)","ACTIVE_COMPARATOR","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.",[13],"Diagnostic Test: Indocyanine Green Angiogram",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"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.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","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.",[19,9,15],[29,30],"ICG-FA","Indocyanine green fluorescence angiography",null,[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Centro Medico Bariatrico","RECRUITING","Tijuana","Estado de Baja California","22046","Mexico","MX",{"type":42,"coordinates":43},"Point",[44,45],-117.00371,32.5027,{"lat":45,"lon":44},[48],{"name":49,"role":50,"phone":51,"phoneExt":31,"email":52},"Manuel A Guerrero Gutierrez, MD","CONTACT","+52 664 274 6273","manuelguerreromd@gmail.com",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR",": Manuel Alberto Guerrero Gutierrez","Study Director",[58],{"name":59,"class":60},"Bariatric Medical Center","UNKNOWN","100592984","indocyanine-green-fluorescence-angiography-icg-fa-in-revisional-bariatric-surgery-100592984",false,"NCT07000539","Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery","Prospective Single-center Diagnostic Parallel-group Study to Determine the Minimal Dose of Indocyanine Green to Observe Vascular Perfussion in Revisional Bariatric Surgery.","BariGreen","Inclusion Criteria:\n\n* Diagnosis of obesity with a BMI ≥ 30 kg\u002Fm²\n* Scheduled for revisional bariatric surgery\n\nExclusion Criteria:\n\n* Allergy to iodides.\n* Anticoagulation with products containing sodium bisulfite (due to the risk of ICG-FA inactivation).\n* Use of radioactive iodine studies within the past 7 days.\n* Pregnant, breastfeeding, or planning to become pregnant within the next year (due to unknown teratogenic or fertility effects of ICG-FA).\n* 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.\n* Participants who withdraw their consent to participate in the study (elimination criterion).","ALL","18 Years",{"count":72,"type":73},108,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.",[79,80],"Obesity","Bariatric Surgery",[82,83,84,85,86,87],"bariatric surgery","indocyanine green","vascular","weight loss surgery","Intraoperative Complications","Postoperative Complications","2026-03-23",{"date":90,"type":91},"2026-03-27","ACTUAL",{"date":93,"type":91},"2025-05-06",{"date":95,"type":73},"2026-12-31",{"name":5,"class":6},1]