EndometriosisESPRITNCT07114081
EndometrioSis PRediction and Assessment of InflammaTion
An observational study of Endometriosis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to develop a non-invasive predictive algorithm for a diagnosis of endometriosis in a group of symptomatic women attending for their first laparoscopic surgical procedure for symptoms that are suspicious for pelvic endometriosis and to understand the role of peripheral markers of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Diagnostic laparoscopy
- How many people
- 264 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult
Study population: Consecutive female patients age 18-50 undergoing gynaecological laparoscopic surgery at included institutions
Who may be able to join
- Consecutive female patients age 18-50 undergoing laparoscopy with the suspicion of endometriosis (as indicated by any recording in secondary care medical notes of endometriosis being a possible finding at laparoscopy; all those undergoing laparoscopy for sub-fertility (no conception after ≥6 months of trying, excluding confirmed male factor); or pelvic pain symptoms (dysmenorrhea; non-cyclical pelvic pain; dyspareunia; dyschezia) who is not otherwise excluded.
Who cannot join
- previous surgically confirmed endometriosis;
- postmenopausal status;
- laparoscopy for acute indication (ectopic; tubo-ovarian abscess; adnexal torsion);
- suspicion of malignancy;
- the sole indication of tubal sterilisation;
- the sole indication of myomectomy;
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- pregnant or breastfeeding;
- significant medical co-morbidities including HIV and/or hepatitis B or C infection;
- where gynaecology is not the primary team undertaking surgery;
- unable to have transvaginal ultrasound (TVUSS);
- declines to take part in the study;
- patient unable to understand verbal or written information in English;
- lack of capacity to consent at the point of recruitment;
- known safeguarding issues.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital NHS Foundation Trust
London
About this study
Official title: Exploring Pre-operative Prediction of Pelvic Endometriosis, the Local Inflammatory Environment and Response to Surgical Treatment
The goal of this observational study is to develop a non-invasive predictive algorithm for a diagnosis of endometriosis in a group of symptomatic women attending for their first laparoscopic surgical procedure for symptoms that are suspicious for pelvic endometriosis and to understand the role of peripheral markers of inflammation in enhancing this diagnosis.
The main questions it aims to answer are:
Can a non-invasive quantitative algorithm ('Endometriosis Diagnostic Index') accurately predict the presence or absence of pelvic endometriosis? Is the peripheral inflammatory environment (for example, presence of inflammatory cytokines and chemokine) different between people with and without endometriosis?
- Conditions
- Endometriosis
- Being tested
- Diagnostic laparoscopy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic laparoscopyDiagnostic test
Minimal access surgery to determine the presence of characteristic endometriosis lesions on visual inspection of the pelvis
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometriosis predictive model
Multiple logistic regression model of predictive variables
Measured: 24 months
Secondary outcomes (1)
Markers of inflammation
Cytokine multiplex for markers of inflammation in peripheral blood
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 posted11 Aug 2025
- Study start1 Jul 2022
- Primary completion1 Feb 2024
- Study completion1 Aug 2025
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.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114081
- Sponsor's protocol ID
- 22/PR/0483
- Acronym
- ESPRIT
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: TBC
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Pre-operative Prediction of Pelvic Endometriosis, the Local Inflammatory Environment and Response to Surgical Treatment
- ClinicalTrials.gov ID
- NCT07114081
- Acronym / sponsor ID
- ESPRIT / 22/PR/0483
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 11 Aug 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.
The goal of this observational study is to develop a non-invasive predictive algorithm for a diagnosis of endometriosis in a group of symptomatic women attending for their first laparoscopic surgical procedure for symptoms that are suspicious for pelvic endometriosis and to understand the role of peripheral markers of inflammation in enhancing this diagnosis.
The main questions it aims to answer are:
Can a non-invasive quantitative algorithm ('Endometriosis Diagnostic Index') accurately predict the presence or absence of pelvic endometriosis? Is the peripheral inflammatory environment (for example, presence of inflammatory cytokines and chemokine) different between people with and without endometriosis?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Consecutive female patients age 18-50 undergoing gynaecological laparoscopic surgery at included institutions
Key inclusion criteria (1 listed)
- Consecutive female patients age 18-50 undergoing laparoscopy with the suspicion of endometriosis (as indicated by any recording in secondary care medical notes of endometriosis being a possible finding at laparoscopy; all those undergoing laparoscopy for sub-fertility (no conception after ≥6 months of trying, excluding confirmed male factor); or pelvic pain symptoms (dysmenorrhea; non-cyclical pelvic pain; dyspareunia; dyschezia) who is not otherwise excluded.
Key exclusion criteria (14 listed)
- previous surgically confirmed endometriosis;
- postmenopausal status;
- laparoscopy for acute indication (ectopic; tubo-ovarian abscess; adnexal torsion);
- suspicion of malignancy;
- the sole indication of tubal sterilisation;
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 |
|---|---|---|
| Diagnostic laparoscopyMinimal access surgery to determine the presence of characteristic endometriosis lesions on visual inspection of the pelvis | Diagnostic test | – |
Primary outcome
Endometriosis predictive model
Time frame: 24 months
Multiple logistic regression model of predictive variables
1 secondary outcome
Markers of inflammation
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No. TBC
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Imperial College London 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 1 inclusion and 14 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: finished, as of the sponsor's last update on 11 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis predictive model (time frame: 24 months). 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 11 Aug 2025.