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

NCT07144904 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: H-57801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ureteral stent placement; indocyanine green; endometriosis; robotic surgery; ureteral identification

Outcome Measures

Primary Outcomes (1)

• Comparison of operative time between the ICG-assisted and standard visualization sides

  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.

  Intraoperative, measured during the surgical procedure on the day of surgery.

Secondary Outcomes (1)

• Incidence of ureter or bladder symptoms or complications & Surgical complication rate by Clavien-Dindo classification

  Postoperative, up to 6 weeks after surgery.

Study Arms (2)

Arm A: ICG-Assisted Ureteral Identification (Unilateral)

EXPERIMENTAL

Participants assigned to this study will undergo intraoperative ureteral identification using indocyanine green (ICG) fluorescence imaging in either left or right side. A temporary ureteral stent will be inserted on the randomized side (left or right) prior to ureterolysis and endometriosis resection. ICG will be administered through the stent to facilitate real-time fluorescence visualization of the ureter during robot-assisted single-site surgery. The contralateral side will serve as the control arm (standard visualization without ICG).

Drug: Indocyanine Green (ICG)-Assisted Ureteral Identification

Arm B: Standard Visualization (Contralateral Control)

ACTIVE COMPARATOR

Participants assigned to this study will undergo intraoperative ureteral identification using indocyanine green (ICG) fluorescence imaging in either left or right side. A temporary ureteral stent will be inserted on the randomized side (left or right) prior to ureterolysis and endometriosis resection. ICG will be administered through the stent to facilitate real-time fluorescence visualization of the ureter during robot-assisted single-site surgery. The contralateral side will serve as the control arm (standard visualization without ICG).

Procedure: Standard Ureteral Identification without ICG

Interventions

Indocyanine Green (ICG)-Assisted Ureteral Identification DRUG

A temporary ureteral stent will be placed unilaterally (left or right) prior to robotic procedures in participants undergoing robot-assisted single-site surgery for advanced-stage endometriosis. Indocyanine green (ICG) will be administered through the stent to enable real-time fluorescence imaging for intraoperative ureter identification. The contralateral ureter will be identified using standard visualization techniques without ICG. Side allocation (ICG vs. control) will be determined by computer-generated block randomization.

Arm A: ICG-Assisted Ureteral Identification (Unilateral)

Standard Ureteral Identification without ICG PROCEDURE

Ureter identification will be performed using standard intraoperative visualization techniques without the use of indocyanine green (ICG) fluorescence imaging. This will be done on the contralateral side to the randomized ICG-assisted ureteral identification during robot-assisted single-site surgery for advanced-stage endometriosis.

Arm B: Standard Visualization (Contralateral Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Childrens Hospital Pavilion for Women

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Endometriosis; Disease

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xiaoming Guan, PhD, MD

  Department Chair of Minimally Invasive Gynecologic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Tims

CONTACT

8328267464; atims@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be informed that the study involves intraoperative indocyanine green (ICG)-assisted ureter identification and that they will be randomized to receive a temporary ICG ureteral stent on either the left or right side. They will be advised that there is a 50% probability of assignment to either side and that they will remain blinded to their allocation throughout the study. Risks and potential benefits of the procedure will be explained, and written informed consent will be obtained. Each participant will be assigned a unique study number for data de-identification prior to randomization, which will be conducted using a computer-generated sequence in REDCap. The operating surgeon will be informed of the assigned side.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Minimally Invasive Gynecologic Surgery

Model Details: This study will be a side-randomized, self-controlled trial where participant 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. No stratification based on preoperative characteristics is planned.The patient will be blinded to their randomization, and the surgeon will be initially blinded as well. Ureteral ICG stent placement will be performed after anesthesia induction and while the surgeon is scrubbing. The assistant surgeon, surgical staff, research assistants, and statisticians will not be blinded.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 15, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)