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Saliva test may spare women from unnecessary surgery for endometriosis

NCT ID NCT06794424

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

2,503 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 43 years

Sex

Female participants only

Healthy volunteers

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

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

  • CHU Lyon Sud

    Pierre-Bénite, 69310, France

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