Saliva test may spare women from unnecessary surgery for endometriosis
NCT ID NCT06794424
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a simple saliva test (Ziwig Endotest) can help doctors make better decisions about managing endometriosis in women with chronic pelvic pain but unclear imaging results. Over 2,500 women will provide a saliva sample, and researchers will compare treatment plans before and after the test results. The goal is to see if the test reduces the number of exploratory surgeries (laparoscopies) and improves patient care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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2,503 people
The number who actually took part.
- Started
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Mar 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 43 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female aged 18 to 43 2. 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. 3. 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\*\*. 4. 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). 5. Woman has dated and signed the consent form. 6. Speaks and understands French 7. Affiliated with the French healthcare system Exclusion Criteria: 1. Endometriosis diagnosed according to imaging protocol positivity criteria 2. Differential diagnosis and/or adenomyosis made 3. History of isolated dysmenorrhea well controlled by hormonal contraception and no immediate desire for pregnancy, 4. Absence of pelvic pain strongly suggestive of endometriosis. 5. Isolated fatigue 6. 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), 7. Infertility work-up (current or previous), with no signs suggestive of endometriosis. 8. Search for recurrence of known endometriosis 9. Laparoscopy for gynecological reasons other than suspected endometriosis 10. History of cancer 11. Pregnant or breast-feeding women 12. Current bacterial or viral infection or less than one month old 13. Participation in an interventional study or in the exclusion period of an interventional study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Lyon Sud
Pierre-Bénite, 69310, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Appendix: the hidden driver of endometriosis pain?
- Allergy pill put to the test against endometriosis pain
- Can ultrasound and tissue clues reveal which endometriosis lesions carry cancer risk?
- Can AI personalize exercise to ease pelvic pain?
- Can AI learn to spot endometriosis and fibroids on ultrasound?