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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00166-45 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
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Ziwig Endotest® ('Endotest') is marketed in several countries, including Switzerland, which was the first country to make it available in 2022. Since February 2025, several French clinical investigation sites have been offering Endotest, developed by Ziwig, under the innovation funding. Initially, this innovation funding enabled 2,500 patients to be included in a clinical trial (ENDOBEST: ID-RCB 2024-A02092-45). Since the end of December 2025, it has been expanded and now covers a further 22,500 patients whose are not included in the trial. This medical device is based on Next-Generation Sequencing combined with analytical algorithms and enables the identification of endometriosis from a saliva sample. This non-invasive test aims to improve patient care by reducing diagnostic delays and guiding treatment strategies.
Despite the available data on its diagnostic performance, the impact of Endotest on patients' quality of life, their emotional experience, their coping strategies, and their care pathways remains insufficiently documented. Indeed, the Endotest result (positive or negative) can significantly influence these various aspects. This cohort study aims to assess the impact of Endotest on patients' quality of life, primarily using validated self-report questionnaires and clinical data from medical records. By including a large sample of patients, this study aims to provide robust and generalisable data that will be useful for clinicians and patients themselves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometriosis cohort performing Ziwig ENDOTEST® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | EHP 5+6, RAND-36 et 6 and 12 months follow-up visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. | Endometriosis-specific quality of life score on the EHP-5 + 6 questionnaire (Endometriosis Health Profile - 11 items). Score goes from 0 to 44. Higher the score is, worse the outcome is. | Day 1, 6 months and 12 months. |
| To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. | Score for each of the 8 dimensions of quality of life on the RAND-36 questionnaire (declined version of the 36-Item Short Form Survey (SF-36)) Score goes from 0 to 100 for each ones of the 8 dimensions. Higher the score is, better the outocome is. | Day 1, 6 months and 12 months |
| To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. | Factors associated with the level of endometriosis-specific quality of life (EHP-5+6 (Endometriosis Health Profile - 11 items)) at 6 months. Score goes from 0 to 44. Higher the score is, worse the outcome is. | 6 months |
| To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. | Factors associated with the level of each of the 8 dimensions of general quality of life (RAND-36 (declined version of the 36-Item Short Form Survey (SF-36)) at 6 months. Score goes from 0 to 100 for each ones of the 8 dimensions. Higher the score is, better the outocome is. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the impact of Endotest on adaptation strategies. | Brief-COPE score (Brief Coping Orientation to Problems Experienced) Score goes from 1 to 4 for the 3 subscales (Problem Focussed, Emotion Focussed, Avoidant) There is no direct correlation between higher/lower scores and better/worse outcomes | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications for the use of Endotest:
Significant difficulty reading and understanding the language of the country in which the participant is located.
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Patient with endometriosis for whom an Endotest is prescribed
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabien Le Floc'h, Project Manager | Contact | +330630447709 | fabien.lefloch@monitoring-force.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Tivoli Ducos | Recruiting | Bordeaux | Gironde | 33000 | France |
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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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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation). |
Number of patients starting an assisted reproductive technology (ART) treatment programme |
| Through study completion, an average of 1 year |
| Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation). | Number of patients for whom the ART treatment plan is amended (e.g. switching from intrauterine insemination to IVF, surgery) | Through study completion, an average of 1 year |
| Describe the impact of Endotest's results immediately following the announcement. | Personalised questionnaire on immediate emotional reactions | 1 month |
| Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy). | Number and type of additional tests or procedures performed (ultrasound, MRI, laparoscopy, etc.). | Through study completion, an average of 1 year |
| Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy). | Initiation or modification of treatments (hormonal, pain relievers, etc.). | Through study completion, an average of 1 year |
| To assess the impact of Endotest on anxiety levels. | Visual Analog Scale Anxiety Score Score goes from 0 to 100 Lower the score is, better the outcome is | 1 month |
| Compare the care provided to patients with a positive Endotest result across participating countries. | Type of coverage and waiting period | Through study completion, an average of 1 year |
| Compare pelvic sensitivity based on Endotest results | Convergences Score for Pelvic-Perineal Pain Score goes from 0 to 10 Lower the score is, better the outcome is. | Day 1 and 12 months |
| Hôpital privé Saint-Grégoire | Not yet recruiting | Saint-Grégoire | Ille-et-Vilaine | 35760 | France |
|
| Groupe Hospitalier Bretagne Sud - GHBS - Lorient | Not yet recruiting | Lorient | Morbihan | 56100 | France |
|
| Hôpital de Mercy - CHR Metz Thionville | Not yet recruiting | Peltre | Moselle | 57245 | France |
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| CHU de Saint Etienne | Not yet recruiting | Saint-Priest-en-Jarez | Pays de la Loire Region | 42270 | France |
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| Centre Hospitalier de Pau | Not yet recruiting | Pau | Pyrénées Atlantiques | 64000 | France |
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| Hôpital Jacques Monod - GH du Havre | Not yet recruiting | Montivilliers | Seine-maritime | 76290 | France |
|
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |