Impact of Ziwig Endotest® on the Management of Patients with Clinical Symptoms of Endometriosis Inconsistent with Their Imaging Work-up

Not Applicable

Not yet recruiting

• Conditions: Endometriosis

• Registration Number: NCT06794424
• Lead Sponsor: ZIWIG

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Submitted: 2025-01-29
• Study Start: 2025-02-01
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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%	After 6 months visits	The criterion is estimated after the test result is known.; Each of these criteria is estimated independently at 3 different times: 1. After knowledge of the test result, management decided by the physician who carried out the inclusion consultation or at the PCR.; 2. At the end of the consultation, shared decision; 3. At 6 months: by the adjudication committee: positive opinion; A hierarchical sequential analysis will be carried out independently according to the following scheme: Sequence 1: decisional impact of the test on the management decision, if conclusive compared with MCID (main criterion) → sequence 2: decisional impact of the test on the medical decision shared with the patient, if conclusive compared with MCID → sequence 3: percentage of favorable adjudications, conclusive if higher than MCID (highest level of evidence of clinical utility)
Changes in subject management related to Ziwig Endotest® result) in women with no prior indication for diagnostic laparoscopy. MCID 30%.	After 6 months visits	The criterion is estimated after the test result is known.; Each of these criteria is estimated independently at 3 different times: 1. After knowledge of the test result, management decided by the physician who carried out the inclusion consultation or at the PCR.; 2. At the end of the consultation, shared decision; 3. At 6 months: by the adjudication committee: positive opinion; A hierarchical sequential analysis will be carried out independently according to the following scheme: Sequence 1: decisional impact of the test on the management decision, if conclusive compared with MCID (main criterion) → sequence 2: decisional impact of the test on the medical decision shared with the patient, if conclusive compared with MCID → sequence 3: percentage of favorable adjudications, conclusive if higher than MCID (highest level of evidence of clinical utility)