NCT06794424Active, not recruiting
Impact of Ziwig Endotest® on the Management of Patients With Clinical Symptoms of Endometriosis Inconsistent With Their Imaging Work-up
Impact of Ziwig Endotest® on the Decision and Management of Patients With Chronic Disabling Pelvic Pain Strongly Suggestive of Endometriosis and Presenting With a Negative or Uncertain Baseline Imaging Workup
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 2503 (actual)
- First submitted
- 20 Jan 2025
- Start date
- 14 Mar 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- ZIWIG
- Diseases
- Endometriosis
- NCT number
- NCT06794424
What you commit to
- Study type: Interventional
- Participants enrolled: 2503
- From 14 Mar 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infertility work-up (current or previous), with no signs suggestive of endometriosis.
Other illness
- History of isolated dysmenorrhea well controlled by hormonal contraception and no immediate desire for pregnancy,
- History of cancer
- Current bacterial or viral infection or less than one month old
Other
- Endometriosis diagnosed according to imaging protocol positivity criteria
- Differential diagnosis and/or adenomyosis made
- 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),
- Search for recurrence of known endometriosis
- Laparoscopy for gynecological reasons other than suspected endometriosis
- Pregnant or breast-feeding women
- Participation in an interventional study or in the exclusion period of an interventional study
Who the study is looking for
- 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).
- Woman has dated and signed the consent form.
- Speaks and understands French
- Affiliated with the French healthcare system
Age in the registry: 18 years to 43 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.