Gynecologic DiseaseIDEA1NCT04171297
Ultrasound Evaluation of the Pelvis in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery
An observational study of Gynecologic Disease and Endometriosis, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
Trial summary
An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gynecologic Disease, Endometriosis, Endometriosis, Rectum
- What is being tested?
- Ultrasound evaluation of DE
- Type of treatment
- Surgery or procedure
- How many people
- 1,866 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Sep 2019to 17 May 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with suspected endometriosis scheduled for laparoscopic surgery.
Who may be able to join
- Patients scheduled for radical laparoscopic endometriosis surgery
Who cannot join
- <18 years
- >45 years
- (suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy
- Premenarche
- Menopause
- Pregnancy
Show all 9Show fewer
- Patients refusal for radical surgery (for example refusal for bowel resection/temporary stoma)
- Surgery performed more than 1 year after ultrasound scan
- Patients refusal to participate to the study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Ultrasound Evaluation of the Pelvis Using the International Deep Endometriosis Analysis (IDEA) Terminology in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery - IDEA 1 Study
An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.
- Conditions
- Gynecologic Disease, Endometriosis, Endometriosis, Rectum, Endometriosis of Colon, Endometriosis of Vagina, Endometriosis Rectovaginal Septum
- Being tested
- Ultrasound evaluation of DE
- Medical subject headings
- Genital Diseases, Female, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound evaluation of DEProcedure or surgery
To evaluate diagnostic accuracy of ultrasound for the presence of deep endometriosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of deep endometriosis
The primary objective is to assess the diagnostic value of the ultrasound features in the diagnosis of deep endometriosis. The endpoints are the univariable diagnostic accuracies of ultrasound features (defined by the IDEA consensus statement) for the presence of deep endometriosis at any location: anterior compartment (i.e. bladder and its specific location) or posterior compartment (i.e. rectovaginal septum, uterosacral ligaments, torus uterinus, vaginal fornix and bowel involvement). All recruited patients are included in this analysis. The reference standard for this objective is whether there is deep endometriosis (at any location) or not (binary outcome).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start25 Sep 2019
- Primary completion31 Dec 2023
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 1,866 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, University of Cagliari
- Responsible party
- Sponsor
- Investigators
- Dirk Timmerman, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171297
- Sponsor's protocol ID
- S63056
- Acronym
- IDEA1
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2019
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Pelvis Using the International Deep Endometriosis Analysis (IDEA) Terminology in Women with Suspected Endometriosis Scheduled for Laparoscopic Surgery - IDEA 1 Study
- ClinicalTrials.gov ID
- NCT04171297
- Acronym / sponsor ID
- IDEA1 / S63056
- Conditions
- Gynecologic Disease, Endometriosis, Endometriosis, Rectum, Endometriosis of Colon, Endometriosis of Vagina, Endometriosis Rectovaginal Septum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,866 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University of Sydney, University of Cagliari
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 20 Nov 2019 (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.
An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with suspected endometriosis scheduled for laparoscopic surgery.
Key inclusion criteria (1 listed)
- Patients scheduled for radical laparoscopic endometriosis surgery
Key exclusion criteria (9 listed)
- <18 years
- >45 years
- (suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy
- Premenarche
- Menopause
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 |
|---|---|---|
| Ultrasound evaluation of DETo evaluate diagnostic accuracy of ultrasound for the presence of deep endometriosis. | Procedure or surgery | – |
Primary outcome
Presence of deep endometriosis
Time frame: 1 year
The primary objective is to assess the diagnostic value of the ultrasound features in the diagnosis of deep endometriosis. The endpoints are the univariable diagnostic accuracies of ultrasound features (defined by the IDEA consensus statement) for the presence of deep endometriosis at any location: anterior compartment (i.e. bladder and its specific location) or posterior compartment (i.e. rectovaginal septum, uterosacral ligaments, torus uterinus, vaginal fornix and bowel involvement). All recruited patients are included in this analysis. The reference standard for this objective is whether there is deep endometriosis (at any location) or not (binary outcome).
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 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Dirk Timmerman, MD, PhD principal investigator
UZ Leuven
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Disease and Endometriosis, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
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 9 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Belgium, Italy. 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?
Presence of deep endometriosis (time frame: 1 year). 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 10 Dec 2024.