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Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery

Sponsor: University Hospitals of North Midlands NHS Trust

NCT ID: NCT06852248

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ureteric stenting (procedure), Indocyanine green (ICG) dye (procedure)
How long the study runs
Study runs about 32 months (dates as stated)
About the drug or intervention
Ureteric stenting — procedure: The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. · Indocyanine green (ICG) dye — procedure: The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 50 Years
Who
Female
Number of participants
70
Started
2025-07-29
Last checked
2025-08

Plain English Summary

What is this study?

  • • Testing a new treatment for endometriosis
  • • Clinical study - 70 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 50 Years
  • • Diagnosed with endometriosis
  • • Female only

Where?

  • • Stoke-on-Trent - University Hospitals of North Midlands NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

EndometriosisDeep Endometriosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 50 Years
  • Who can join: Female only

What 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...
  • ✓Willing and able to provide consent for participation in the study

Who cannot take part

  • ✗Confirmed or suspected pregnancy at the time of enrolment.
  • ✗Suspicion or confirmation of cancer.
  • ✗History of ureteric injury from prior surgery or trauma
  • ✗Medically unfit for surgery due to the following conditions:
  • ✗Uncontrolled diabetes mellitus.
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Confirmed or suspected pregnancy at the time of enrolment. * Suspicion or confirmation of malignancy. * History of ureteric injury from prior surgery or trauma * 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. * Body mass index (BMI): BMI greater than 45

Where Is This Study? (1 UK site)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting
Site contact (verified)
Gourab MisraPrincipal Investigator

How to Get in Touch

Aviva Ogbolosingha

Sponsor contact

CONTACT

01782675380 aviva.ogbolosingha@uhnm.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-08