NCT06852248Recruiting
Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery
Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery: A Pilot Trial (ICE Trial)
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Endometriosis is a common (around 1 in 10 women), non-cancerous condition where tissue similar to the womb lining is found growing elsewhere, most commonly inside the pelvis. Symptoms vary but can include intense pelvic pain and infertility. Endometriosis that is very deep and painful may need surgery, which risks damage to the tubes that drain urine from the kidneys to the bladder (ureters). To reduce this risk, surgeons may put tiny plastic tubes called "stents" inside the ureters. These stents can stay for up-to 4 weeks following surgery but can cause severe pain and blood in the urine. Squirting a dye into the ureters, rather than using stents, may cause less pain for women after surgery whilst not making the removal of endometriosis worse, the operation take longer, or increasing the rates of complications (such as bleeding or damage to internal organs). Before a full clinical study can be run, the investigators need to understand whether this is possible, by doing a feasibility study
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 29 Jul 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Diseases
- Endometriosis
- NCT number
- NCT06852248
What you commit to
- Study type: Observational
- Planned participants: 70
- From 29 Jul 2025 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of ureteric injury from prior surgery or trauma
Other illness
- Suspicion or confirmation of malignancy.
- Medically unfit for surgery due to the following conditions:
- Uncontrolled diabetes mellitus.
- Severe Chronic Obstructive Pulmonary Disease (COPD).
- Hypertrophic cardiomyopathy or significant cardiac conditions (e.g., recent myocardial infarction, aortic stenosis).
- History of stroke or severe kyphoscoliosis.
- Uncontrolled hypertension.
Other
- Confirmed or suspected pregnancy at the time of enrolment.
- Body mass index (BMI): BMI greater than 45
Who the study is looking for
- Women aged 18 to 50 years
- Scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis (DE) where ureteric stenting is planned.
- Willing and able to provide consent for participation in the study
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of North Midlands NHS Trust Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.