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

NCT ID: NCT06794424

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-09-01

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.

Conditions

Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Performing Ziwig Endotest®

Group Type: EXPERIMENTAL

Ziwig Endotest®

Intervention Type: DIAGNOSTIC_TEST

Saliva sampling for Endometriosis diagnostic

Interventions

Ziwig Endotest®

Saliva sampling for Endometriosis diagnostic

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Monitoring Force Group

INDUSTRY

Sponsor Role: collaborator

ZIWIG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

François GOLFIER, Pr

Role: CONTACT

francois.golfier@chu-lyon.fr

+33 4 78 86 41 78

Other Identifiers

ZWG-24-04

Identifier Type: -

Identifier Source: org_study_id