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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
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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:
Study will compare the patient management decision before and after the test.
The acts and procedures performed as part of this research are :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Performing Ziwig Endotest® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziwig Endotest® | Diagnostic Test | Saliva sampling for Endometriosis diagnostic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) | 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:
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) | After 6 months visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lyon Sud | Pierre-Bénite | 69310 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D000091662 | Genital Diseases |