Analytical Evaluation of the Endotest® Diagnostic (ENDORepro)

March 23, 2026 updated by: ZIWIG

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Clinique Tivoli
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • CHU de ROUEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Research Planning

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.
Device: Salivary Sampling

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through the end of repeatibility study, an average of 3 months
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)
Through the end of repeatibility study, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 absence of variation during the day of the results of the Endotest® Diagnostic
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
To evaluate the absence of variation during the day of the results of the Endotest® Diagnostic
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
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
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
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
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
To evaluate the stability of the samples once they are collected
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
To evaluate the stability of the samples once they are collected
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
To evaluate the absence of interference on the analytical method and the signature
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
To evaluate the absence of interference on the analytical method and the signature
Through the end of repeatibility study, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZIWIG

Collaborators

Monitoring Force Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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