Indocyanine Green for Endometriosis

Overseen By Ann Tims

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Baylor College of Medicine

Disqualifiers: Prisoners, Under 18, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Xiaoming Guan, PhD, MD

Principal Investigator

Department Chair of Minimally Invasive Gynecologic Surgery

Are You a Good Fit for This Trial?

This trial is for individuals with advanced-stage endometriosis undergoing robot-assisted surgery. Participants should not have liver disease or conditions that affect indocyanine green (ICG) usage. The study excludes those who cannot receive ICG, are pregnant, or have other medical issues that could interfere with the trial.

Inclusion Criteria

My condition is advanced endometriosis (stage III or IV).

I am scheduled for a robotic surgery to remove endometriosis, possibly including a hysterectomy.

Exclusion Criteria

I am not a prisoner, under 18, pregnant, or have mental disabilities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo robot-assisted single-site surgery with ICG-assisted ureteral identification

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of postoperative symptoms and complications

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green (ICG)-Assisted Ureteral Identification

Trial Overview The study tests if using a dye called Indocyanine Green (ICG) helps surgeons see the ureters better during robotic surgery for endometriosis. Half of the patients will get ICG on one side of their body by chance to see if it reduces surgery time and lowers injury risk.

How Is the Trial Designed?

Group I: Arm A: ICG-Assisted Ureteral Identification (Unilateral) Experimental Treatment 1 Intervention

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).

Group II: Arm B: Standard Visualization (Contralateral Control) Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+