Indocyanine Green for Ureter Identification in Endometriosis Surgery

This study is looking at whether using Indocyanine Green (ICG) can help doctors better see the ureters (tubes that carry urine from the kidneys to the bladder) during robot-assisted surgery for advanced endometriosis. Endometriosis is a condition where tissue similar to the lining of the uterus grows outside the uterus. You would have a temporary tube placed in one ureter, and ICG would be given through it to make that ureter light up during surgery. The other ureter would be identified using standard methods. Researchers want to see if using ICG makes it faster to identify the ureters. This study is for women aged 18 and older with Stage III or IV endometriosis who are having robotic surgery.

Study design
This is a side-randomized, self-controlled study with a planned enrollment of 40 participants. You will receive ICG-assisted ureter identification on one side and standard identification on the other.
What's involved
You will undergo a robot-assisted single-site surgery for advanced-stage endometriosis. A temporary ureteral stent will be placed, and ICG will be administered during the procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, operative time, is measured during the surgical procedure on the day of surgery. No further follow-up is specified.

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NCT07144904

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

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
Baylor College of Medicine
~40 participants
Updated 2025-08-28 on ClinicalTrials.gov
What's tested:Indocyanine Green (ICG)-Assisted Ureteral IdentificationStandard Ureteral Identification without ICG

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of operative time between the ICG-assisted and standard visualization sides
Measured over Intraoperative, measured during the surgical procedure on the day of surgery.
Indocyanine Green (ICG)
Robotic Surgical Procedure
Deep Infiltrating Endometriosis (DIE)
Endometriosis Pelvic
Endometriosis (Diagnosis)
Endometriosis of the Cul-de-sac
Ureteral Stent Placement
Ureteral Injury
Endometriosis Ovaries
1 sites across 1 states
Texas1
  • Xiaoming Guan, PhD, MD · PRINCIPAL_INVESTIGATOR · Department Chair of Minimally Invasive Gynecologic Surgery

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Eligibility criteria

Inclusion

Stage III or IV endometriosis (rASRM classification)
Planned robotic transabdominal endometriosis excision with or without hysterectomy.
  • Comparison of operative time between the ICG-assisted and standard visualization sidesIntraoperative, measured during the surgical procedure on the day of surgery.

    Total operative time was calculated for each side, as well as for each individual procedure. The total operative time represents the sum of the operative times for all individual procedures performed.