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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special dye, Indocyanine Green (ICG), can help doctors better visualize the ureters (tubes that carry urine from the kidneys to the bladder) during surgery for advanced endometriosis. By using ICG during robotic surgery, the researchers hope to make the operation quicker and safer by reducing the risk of injuring these tubes. Women diagnosed with advanced-stage endometriosis and planning to undergo robotic surgery for its removal might be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients, offering an opportunity to contribute to improved surgical outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Indocyanine Green (ICG)-Assisted Ureteral Identification?

Research has shown that Indocyanine Green (ICG), a dye used in surgeries, is generally safe for people. In one study, ICG helped doctors visualize the ureters—tubes that carry urine from the kidneys to the bladder—during surgery without causing harm. Another study found that using ICG in surgeries for endometriosis, a condition where tissue similar to the uterine lining grows outside it, is both safe and helpful. ICG has also been used in other surgeries to identify endometriosis tissue. Overall, evidence suggests that ICG is well-tolerated and usually does not cause serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard surgical techniques for endometriosis, which rely on visual identification of the ureters, Indocyanine Green (ICG)-assisted ureteral identification uses fluorescence imaging to highlight the ureters in real-time during surgery. This novel method could significantly reduce the risk of ureteral injury, a common complication in endometriosis surgeries. Researchers are excited about this approach because it allows for more precise and safer surgical intervention, potentially improving outcomes for patients with endometriosis while minimizing complications.

What evidence suggests that Indocyanine Green is effective for ureter identification in endometriosis surgery?

Research has shown that Indocyanine Green (ICG) helps surgeons visualize the ureters, the tubes connecting the kidneys to the bladder, during surgery. In this trial, participants in Arm A will undergo ICG-assisted ureteral identification on one side, while the other side will serve as the control with standard visualization. Studies indicate that ICG simplifies the identification of endometriosis lesions and distinguishes them from healthy tissue, reducing the risk of ureter damage during surgery. ICG has also proven safe and effective in improving surgical outcomes, providing a clearer view in complex cases, which can make surgeries quicker and safer. ^{1 2 3 6 7}

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+

Citations

1. nature.com nature.com/articles/s41598-025-05082-1

Fluorescence-guided ureteral identification in robotic ... This study aimed to evaluate the safety and surgical outcomes of using Indocyanine Green (ICG) under near-infrared fluorescence for intraoperative ureteral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11476485/

The Role of Indocyanine Green With Near-Infrared Imaging for ... Results: NIR-ICG was found to enhance the detection of endometriosis in six out of the nine included studies with additional lesion ...

3. fvvo.eu fvvo.eu/articles/improving-efficacy-and-safety-of-surgery-in-benign-gynaecology-the-case-for-indocyanine-green/FVVO.2025.94

Improving efficacy and safety of surgery in benign ... It also aids detection of endometriosis lesions, though diagnostic accuracy remains variable. ICG is safe and feasible, with growing evidence ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521693424000518

“The Green Peace” How ICG can prevent complications in ... ICG aids in identifying endometrial lesions, particularly in complex cases of DE. It helps differentiate between endometriotic and healthy tissues, reducing ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06852248

Ureteric Identification Using Indocyanine Green Dye ... The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05206279

ICG for Visualization of the Ureters in DIE (Lavic) The investigators investigate if ICG helps to visualize the ureter in laparoscopic operations for deep infiltrating endometriosis and possibly could help ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1553465024013852

12359 Application of Indocyanine Green (ICG) for ... Use of ICG firefly technology for identification of the ureter during ureterolysis for complex endometriosis resection. Measurements and Main Results.