Impact of Ziwig Endotest® on the Management of Patients With Clinical Symptoms of Endometriosis I… (NCT06794424) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of Ziwig Endotest® on the Management of Patients With Clinical Symptoms of Endometriosis Inconsistent With Their Imaging Work-up
France2,503 participantsStarted 2025-03-14
Plain-language summary
The goal of this study is to evaluate the impact of Ziiwg Endotest on patient management decisions before and after the test. The main questions it aims to answer are:
* Does the test reduce the intention and number of laparoscopies in women whose decision to undergo laparoscopy was made before the test result was obtained?
* Does the test change management decisions in women with no prior indication for diagnostic laparoscopy?
Study will compare the patient management decision before and after the test.
The acts and procedures performed as part of this research are :
* Aa saliva sampling (Ziwig Endotest) at inclusion
* A mutidisciplinary meeting post test (if applicable)
* Completion at inclusion and 6 month of a quality-of-life questionnaire (EHP-5)
* Completion at inclusion and 6 month of a VAS for pain
* Completion at inclusion and 6 month of a Likert satisfaction scale
* A test results Announcement consultation
* A visit at 6 months.
Who can participate
Age range
18 Years – 43 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female aged 18 to 43
. Strong clinical suspicion of endometriosis based on the following suggestive symptoms: chronic pelvic pain (\> 6 months) that is suggestive and disabling (ENA ≥ 8, absenteeism or resistance to level 1 analgesics) ± deep dyspareunia or painful hematuria/micturition with menstrual rhythm or painful rectal discharge/defecation with menstrual rhythm.
. Endovaginal ultrasound and MRI (unless contraindicated, in which case only one of the 2 examinations is required\*) less than 1 year old and of sufficient quality , in compliance with the endometriosis protocol recommended by the HAS\*\*.
. Clinical-radiological discrepancy confirmed by the investigating gynecologist and a referent radiologist at the investigating center, in compliance with the protocol's positivity criteria and the French ENDOVALIRM guidelines (for characterizing deep lesions on MRI) and/or the ESUR 2017 guidelines (for ovarian lesions) and/or the SUR-US 2024 guidelines (for ultrasound).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the number of laparoscopies related to the test result in women whose decision to undergo laparoscopy was made in multidiscplinary meeting before the test result was obtained. MCID 20%
Timeframe: After 6 months visits
2
Changes in subject management related to Ziwig Endotest® result) in women with no prior indication for diagnostic laparoscopy. MCID 30%.
. Endometriosis diagnosed according to imaging protocol positivity criteria
. Differential diagnosis and/or adenomyosis made
. History of isolated dysmenorrhea well controlled by hormonal contraception and no immediate desire for pregnancy,
. Absence of pelvic pain strongly suggestive of endometriosis.
. Isolated fatigue
. Aetiological work-up incomplete or pending before deciding on initial medical decision (infertility work-up in progress, waiting for specialist opinion (algologist, psychologist, etc.), waiting for important test results),
. Infertility work-up (current or previous), with no signs suggestive of endometriosis.