drugset / Trial / NCT07144904

Assessing the Efficacy of Indocyanine Green for Ureter Identification During Robot-Assisted Surgery in Advanced-Stage Endometriosis

NCT07144904

Phase 4 Not yet recruiting 40 enrolled Baylor College of Medicine
RandomizedCrossoverSingle-blindTreatment

Summary

The goal of this side-randomized, self-controlled trial, 1-site study is to explore the efficacy of Indocyanine Green Fluorescence (ICG) for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis. Researchers will perform temporary ureteral stent using indocyanine green fluorescence for intraoperative ureteral identification on either the left or right side of subjects who are undergoing a robotic assisted transumbilical resection of advanced endometriosis. Participants will be randomized to receive ICG-assisted ureteral identification on either the left or right side. Randomization will be conducted using a computer-generated block randomization method. The primary aim is to determine whether ICG-assisted ureter visualization can reduce operative time for endometriosis resection and ureterolysis, and minimize the risk of ureteral injury. Secondary objectives are to assess the feasibility and safety of temporary ureteral ICG stenting for intraoperative ureter identification in advanced endometriosis.

Timeline

Start
2025-10-01
Primary completion
2026-02-01
Completion
2026-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 25 mg Other