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Not yet taking people in United StatesPhase 4

Testing indocyanine green dye to spot the ureter during endometriosis surgery

Tests indocyanine green dye to help find the ureter during robot-assisted surgery for advanced endometriosis.

Plain-language title generated from the registry record
Registry title: Assessing the Efficacy of Indocyanine Green for Ureter Identification During Robot-Assisted Surgery in Advanced-Stage Endometriosis

Key facts

Where
Houston, United StatesSee the site
Phase
Phase 4

Where in United States

  • Texas Childrens Hospital Pavilion for WomenHouston, United StatesNo longer taking part

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Trial details

Who runs it
Baylor College of Medicine
Trial code
NCT07144904
Record updated
28 August 2025
Original description
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.Read full original descriptionShow less

A Side-Randomized, Self-Controlled Trial Assessing the Efficacy of Indocyanine Green Fluorescence Imaging for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis

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.

Inclusion: Stage III or IV endometriosis (rASRM classification); Planned robotic transabdominal endometriosis excision with or without hysterectomy.

Exclusion: Subjects who are part of a vulnerable population will be excluded including those who are prisoners, younger than 18 years old, pregnant, individuals with mental disabilities or cognitive impairment.

ClinicalTrials.gov NCT07144904