EndometriosisENDOReproNCT06072820
Analytical Evaluation of the Endotest® Diagnostic
A study testing Salivary Sampling in people with Endometriosis and Diagnosis, run by ZIWIG at 2 sites in France.
Trial summary
This is an interventional with minimal risks and constraints (RIPH 2 in France), prospective, longitudinal, non-randomized, multicenter study. The present study will allow us to evaluate multiple factors assessing the Endotest® Diagnostic accuracy and its possible limitations. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Endometriosis, Diagnosis
- What is being tested?
- Salivary Sampling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject aged 18 years to 43 years,
- Subject having dated and signed the consent form,
- Subject affiliated to the French health system,
- Subject able to return for a full day for the rest of the study,
- Subject whose diagnosis of endometriosis has been established with certainty or definitively ruled out.
- Non-Inclusion criteria:
Show all 14Show fewer
- Pregnant subject,
- Subject with an acute or chronic infection (viral hepatitis, HIV...),
- Subject with history of hypersensitivity or allergy,
- Subject with a personal history of cancer,
- Subjects with significant difficulties in reading or writing the French language,
- Subject unable to comply with the study and/or follow-up procedures,
- Subject who has objected to the collection of her data,
- Subject participating in an interventional study or in the exclusion period of an interventional study.
Who cannot join
- Pregnant subject,
- Subject with acute or chronic infection (viral hepatitis, HIV...),
- Subject unable to comply with study and/or follow-up procedures (including absence of outside salivary sample after the inclusion visit),
- Subject participating in an interventional study or in the exclusion period of an interventional study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Tivoli
Bordeaux, Gironde, 33000
CHU de Rouen
Rouen, Seine-Maritime, 76000
About this study
This is an interventional with minimal risks and constraints (RIPH 2 in France), prospective, longitudinal, non-randomized, multicenter study.
The present study will allow us to evaluate multiple factors assessing the Endotest® Diagnostic accuracy and its possible limitations. To characterize the Endotest® Diagnostic, the following parameters will be evaluated:
Read more
- Repeatability: the verification of the invariability of its results without condition changes,
- Circadian cycle: whether the circadian cycle affects the determination of the signature,
- Intermediate fidelity: the verification of the invariability of its results with an operator change,
- Interferences: the impact of different interferences on its results,
- Stability: the possible modification of its results depending on the samples conditions of storage.
The acts and procedures performed in this research will be divided into three visits:
- Inclusion visit: performance of 4 Endotest® Diagnostics (3 at the visit and 1 at home) by the 60 included subjects,
- "Circadian cycle" visit: performance of 17 Endotest® Diagnostics (14 at the visit and 3 post-visit at home) by 6 subjects selected after evaluation of the results of the inclusion visit,
- "Repeatability-intermediate fidelity-interference-stability" visit: realization of 17 Endotest® Diagnostic by 10 or 16 subjects, depending on the results of the impact of the circadian cycle on the saliva signature. These subjects will be selected according to the results of the inclusion visit, excluding those who participated in the circadian cycle visit.
- Conditions
- Endometriosis, Diagnosis
- Being tested
- Salivary Sampling
- Keywords
- Endometriosis, Diagnosis, Saliva sample, Repeatibility, Circadian cycle, Interferences, Stability
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary SamplingDevice
Inclusion visit: After signature of the informed consent, all subjects will perform 3 consecutive Endotest® Diagnostic during the visit and 1 at-home.
Circadian circle visit: 6 included subjects will be asked to come back for a full day. They will have to perform 17 Endotest® Diagnostic: 14 on study site and 3 at home after the visit.
Repeatability-intermediate fidelity-stability-interferences visit: a maximum of 16 included subjects will be asked to come back for this visit. They will have to perform 17 Endotest® Diagnostic: 14 on study site and 3 at home after the visit.
| Study group | Role | What they receive |
|---|---|---|
| Research Planning | Other | Study population will be composed of subject with a confirmed or ruled-out diagnosis of endometriosis. The subject diagnosis could be ascertained through imaging and/or surgery with or without biopsies.
After a first assessment during a routing care visit, the subject will be asked to come back for a day, or half a day depending on the impact of the circadian cycle. Receives: Device: Salivary Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
Measured: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (Yes/No) of the Endotest® Diagnostic
- evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
Measured: Through the end of repeatibility study, an average of 3 months
Secondary outcomes (8)
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the absence of variation during the day of the results of the Endotest® Diagnostic
Measured: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the absence of variation during the day of the results of the Endotest® Diagnostic
Measured: Through the end of repeatibility study, an average of 3 months
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
Measured: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
Measured: Through the end of repeatibility study, an average of 3 months
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the stability of the samples once they are collected
Measured: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the stability of the samples once they are collected
Measured: Through the end of repeatibility study, an average of 3 months
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the absence of interference on the analytical method and the signature
Measured: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the absence of interference on the analytical method and the signature
Measured: Through the end of repeatibility study, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Study split into two independants studies
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
- 0 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
- NCT06072820
- Sponsor's protocol ID
- 2023-03
- Acronym
- ENDORepro
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Evaluation of the Endotest® Diagnostic
- ClinicalTrials.gov ID
- NCT06072820
- Acronym / sponsor ID
- ENDORepro / 2023-03
- Conditions
- Endometriosis, Diagnosis
- Keywords
- Endometriosis, Diagnosis, Saliva sample, Repeatibility, Circadian cycle, Interferences, Stability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study split into two independants studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ZIWIGIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
This is an interventional with minimal risks and constraints (RIPH 2 in France), prospective, longitudinal, non-randomized, multicenter study.
The present study will allow us to evaluate multiple factors assessing the Endotest® Diagnostic accuracy and its possible limitations. To characterize the Endotest® Diagnostic, the following parameters will be evaluated:
- Repeatability: the verification of the invariability of its results without condition changes,
- Circadian cycle: whether the circadian cycle affects the determination of the signature,
- Intermediate fidelity: the verification of the invariability of its results with an operator change,
- Interferences: the impact of different interferences on its results,
- Stability: the possible modification of its results depending on the samples conditions of storage.
The acts and procedures performed in this research will be divided into three visits:
- Inclusion visit: performance of 4 Endotest® Diagnostics (3 at the visit and 1 at home) by the 60 included subjects,
- "Circadian cycle" visit: performance of 17 Endotest® Diagnostics (14 at the visit and 3 post-visit at home) by 6 subjects selected after evaluation of the results of the inclusion visit,
- "Repeatability-intermediate fidelity-interference-stability" visit: realization of 17 Endotest® Diagnostic by 10 or 16 subjects, depending on the results of the impact of the circadian cycle on the saliva signature. These subjects will be selected according to the results of the inclusion visit, excluding those who participated in the circadian cycle visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Planning | Other | Device: Salivary SamplingStudy population will be composed of subject with a confirmed or ruled-out diagnosis of endometriosis. The subject diagnosis could be ascertained through imaging and/or surgery with or without biopsies. After a first assessment during a routing care visit, the subject will be asked to come back for a day, or half a day depending on the impact of the circadian cycle. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subject aged 18 years to 43 years,
- Subject having dated and signed the consent form,
- Subject affiliated to the French health system,
- Subject able to return for a full day for the rest of the study,
- Subject whose diagnosis of endometriosis has been established with certainty or definitively ruled out.
Key exclusion criteria (4 listed)
- Pregnant subject,
- Subject with acute or chronic infection (viral hepatitis, HIV...),
- Subject unable to comply with study and/or follow-up procedures (including absence of outside salivary sample after the inclusion visit),
- Subject participating in an interventional study or in the exclusion period of an interventional study.
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 |
|---|---|---|
| Salivary SamplingInclusion visit: After signature of the informed consent, all subjects will perform 3 consecutive Endotest® Diagnostic during the visit and 1 at-home. Circadian circle visit: 6 included subjects will be asked to come back for a full day. They will have to perform 17 Endotest® Diagnostic: 14 on study site and 3 at home after the visit. Repeatability-intermediate fidelity-stability-interferences visit: a maximum of 16 included subjects will be asked to come back for this visit. They will have to perform 17 Endotest® Diagnostic: 14 on study site and 3 at home after the visit. | Device | Research Planning |
Primary outcome
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Time frame: Through the end of repeatibility study, an average of 3 months
To evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
Change from baseline in the result (Yes/No) of the Endotest® Diagnostic
Time frame: Through the end of repeatibility study, an average of 3 months
o evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
8 secondary outcomes
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Time frame: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Time frame: Through the end of repeatibility study, an average of 3 months
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Time frame: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Time frame: Through the end of repeatibility study, an average of 3 months
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Time frame: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Time frame: Through the end of repeatibility study, an average of 3 months
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Time frame: Through the end of repeatibility study, an average of 3 months
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Time frame: Through the end of repeatibility study, an average of 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salivary Sampling in people with Endometriosis and Diagnosis, run by ZIWIG at 2 sites 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 14 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 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 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable (time frame: Through the end of repeatibility study, an average of 3 months). 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 27 Mar 2026.