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Study split into two independants studies
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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
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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:
The acts and procedures performed in this research will be divided into three visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salivary Sampling | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Through the end of repeatibility study, an average of 3 months |
| Change from baseline in the result (Yes/No) of the Endotest® Diagnostic | o evaluate the repeatability of Endotest® Diagnostic (analytical method and signature) | Through the end of repeatibility study, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through the end of repeatibility study, an average of 3 months |
| Change from baseline in the result (positive/negative) of the Endotest® Diagnostic |
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Inclusion Criteria:
Non-Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Tivoli | Bordeaux | Gironde | 33000 | France | ||
| CHU de Rouen |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 | 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 | 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 | 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 | 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 | 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 | To evaluate the absence of interference on the analytical method and the signature | Through the end of repeatibility study, an average of 3 months |
| Rouen |
| Seine-Maritime |
| 76000 |
| France |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |