EndometriosisENDOBESTNCT06794424
Impact of Ziwig Endotest® on the Management of Patients With Clinical Symptoms of Endometriosis Inconsistent With Their Imaging Work-up
A study testing Ziwig Endotest® in people with Endometriosis, run by ZIWIG at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Ziwig Endotest®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,503 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Endometriosis diagnosed according to imaging protocol positivity criteria
- Differential diagnosis and/or adenomyosis made
- History of isolated dysmenorrhea well controlled by hormonal contraception and no immediate desire for pregnancy,
- 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),
Show all 13Show fewer
- Infertility work-up (current or previous), with no signs suggestive of endometriosis.
- Search for recurrence of known endometriosis
- Laparoscopy for gynecological reasons other than suspected endometriosis
- History of cancer
- Pregnant or breast-feeding women
- Current bacterial or viral infection or less than one month old
- Participation in an interventional study or in the exclusion period of an interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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?
Read more
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
- Being tested
- Ziwig Endotest®
- Keywords
- Endometriosis, Endotest, Management of endometriosis, Clinical and radiological discrepancies
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziwig Endotest®Diagnostic test
Saliva sampling for Endometriosis diagnostic
| Study group | Role | What they receive |
|---|---|---|
| Performing Ziwig Endotest® | Experimental | Not described Receives: Diagnostic Test: Ziwig Endotest® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
The criterion is estimated after the test result is known.
Each of these criteria is estimated independently at 3 different times:
- After knowledge of the test result, management decided by the physician who carried out the inclusion consultation or at the PCR.
- At the end of the consultation, shared decision
- 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)
Measured: After 6 months visits
Changes in subject management related to Ziwig Endotest® result) in women with no prior indication for diagnostic laparoscopy. MCID 30%.
The criterion is estimated after the test result is known.
Each of these criteria is estimated independently at 3 different times:
- After knowledge of the test result, management decided by the physician who carried out the inclusion consultation or at the PCR.
- At the end of the consultation, shared decision
- 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)
Measured: After 6 months visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start14 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,503 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZIWIG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794424
- Sponsor's protocol ID
- ZWG-24-04
- Acronym
- ENDOBEST
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06794424
- Acronym / sponsor ID
- ENDOBEST / ZWG-24-04
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Endotest, Management of endometriosis, Clinical and radiological discrepancies
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,503 participants (actual)
- Lead sponsor
- ZIWIGIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Performing Ziwig Endotest® | Experimental | Diagnostic Test: Ziwig Endotest® |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- Endometriosis diagnosed according to imaging protocol positivity criteria
- Differential diagnosis and/or adenomyosis made
- History of isolated dysmenorrhea well controlled by hormonal contraception and no immediate desire for pregnancy,
- Absence of pelvic pain strongly suggestive of endometriosis.
- Isolated fatigue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziwig Endotest®Saliva sampling for Endometriosis diagnostic | Diagnostic test | Performing Ziwig Endotest® |
Primary outcome
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%
Time frame: 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%.
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ziwig Endotest® in people with Endometriosis, run by ZIWIG at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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% (time frame: After 6 months visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.