EndometriosisICENCT06852248
Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery
An observational study of Endometriosis and Deep Endometriosis, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Deep Endometriosis
- What is being tested?
- Ureteric stenting and Indocyanine green (ICG) dye
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jul 2025to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with deep endometriosis
Who may be able to join
- 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
Who cannot join
- 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).
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
Aviva Ogbolosingha
Gourab Misra
About this study
Official title: 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)
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
- Conditions
- Endometriosis, Deep Endometriosis
- Being tested
- Ureteric stenting, Indocyanine green (ICG) dye
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteric stentingProcedure or surgery
The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will have conventional ureteric stenting (temporary tubes placed in the ureters)
Indocyanine green (ICG) dyeProcedure or surgery
The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light.
| Study group | Role | What they receive |
|---|---|---|
| Ureteric stenting | One group will have conventional ureteric stenting (temporary tubes placed in the ureters). Receives: Procedure: Ureteric stenting | |
| Indocyanine green (ICG) dye | One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light. Receives: Procedure: Indocyanine green (ICG) dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible women
The number of eligible women across 2 UK sites that are suitable for trial recruitment
Measured: 24 months
Proportion of eligible women agreeing to participate
Number of women who are eligible that then take part in the trial
Measured: 24 months
Attrition rate in follow up process
Recording the percentage of people who drop out before the completion
Measured: 24 months
Missing data in follow up process
Recording how much data is missing from the follow up data
Measured: 24 months
Acceptability of the trial interventions and follow-up processes
Recording how acceptable surgeons find the trial interventions and follow up process.
Measured: 24 months
Acceptability of the trial interventions and follow-up processes
Recording how acceptable participants find the trial interventions and follow up process. This will be done using a focus group
Measured: 24 months
Reasons for declining participation or withdrawal after agreeing to participate
Recording the list of reasons people withdraw from the study or decline to take part
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start29 Jul 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852248
- Sponsor's protocol ID
- LPR 3359
- Acronym
- ICE
- Status last verified
- Aug 2025
- First submitted
- 18 Feb 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06852248
- Acronym / sponsor ID
- ICE / LPR 3359
- Conditions
- Endometriosis, Deep Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ureteric stenting | – | Procedure: Ureteric stentingOne group will have conventional ureteric stenting (temporary tubes placed in the ureters). |
| Indocyanine green (ICG) dye | – | Procedure: Indocyanine green (ICG) dyeOne group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with deep endometriosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- Body mass index (BMI): BMI greater than 45
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteric stentingThe ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will have conventional ureteric stenting (temporary tubes placed in the ureters) | Procedure or surgery | Ureteric stenting |
| Indocyanine green (ICG) dyeThe ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light. | Procedure or surgery | Indocyanine green (ICG) dye |
Primary outcome
Number of eligible women
Time frame: 24 months
The number of eligible women across 2 UK sites that are suitable for trial recruitment
Proportion of eligible women agreeing to participate
Time frame: 24 months
Number of women who are eligible that then take part in the trial
Attrition rate in follow up process
Time frame: 24 months
Recording the percentage of people who drop out before the completion
Missing data in follow up process
Time frame: 24 months
Recording how much data is missing from the follow up data
Acceptability of the trial interventions and follow-up processes
Time frame: 24 months
Recording how acceptable surgeons find the trial interventions and follow up process.
Acceptability of the trial interventions and follow-up processes
Time frame: 24 months
Recording how acceptable participants find the trial interventions and follow up process. This will be done using a focus group
Reasons for declining participation or withdrawal after agreeing to participate
Time frame: 24 months
Recording the list of reasons people withdraw from the study or decline to take part
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Deep Endometriosis, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aviva Ogbolosingha (01782675380, aviva.ogbolosingha@uhnm.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible women (time frame: 24 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.