Impact of Endotest on Patients' Quality of Life: a Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire.
- Who it may be relevant to
- Registry conditions: Patient With a Prescribed Endotest, Endometriosis (Diagnosis). Basic parameters: 18 years — 43 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Questionnaire
EHP 5+6, RAND-36 et 6 and 12 months follow-up visits
Primary outcome measures
- To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. [Time frame: 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. [Time frame: 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. [Time frame: 6 months]
- To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. [Time frame: 6 months]
Secondary outcome measures (9)
- Describe the impact of Endotest on adaptation strategies. [Time frame: 6 months]
- Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation). [Time frame: 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). [Time frame: Through study completion, an average of 1 year]
- Describe the impact of Endotest's results immediately following the announcement. [Time frame: 1 month]
- Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy). [Time frame: Through study completion, an average of 1 year]
- Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy). [Time frame: Through study completion, an average of 1 year]
- To assess the impact of Endotest on anxiety levels. [Time frame: 1 month]
- Compare the care provided to patients with a positive Endotest result across participating countries. [Time frame: Through study completion, an average of 1 year]
- Compare pelvic sensitivity based on Endotest results [Time frame: Day 1 and 12 months]
Eligibility criteria
Inclusion criteria
- Women with a prescription for Endotest
- Women aged 18 to 43
- Who have dated and signed the consent form
- Affiliated with the French healthcare system or covered by health insurance abroad
Exclusion criteria
- Contraindications for the use of Endotest:
- Current pregnancy;
- Medical history of cancer or HIV infection;
- Active infection at the time of saliva collection;
- Significant difficulty reading and understanding the language of the country in which the participant is located.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 7 centers
- Clinique Tivoli Ducos — Bordeaux
- Hôpital privé Saint-Grégoire — Saint-Grégoire
- Groupe Hospitalier Bretagne Sud - GHBS - Lorient — Lorient
- Hôpital de Mercy - CHR Metz Thionville — Peltre
- CHU de Saint Etienne — Saint-Priest-en-Jarez
- Centre Hospitalier de Pau — Pau
- Hôpital Jacques Monod - GH du Havre — Montivilliers
Identifiers
NCT: NCT07560852 · 2025ZW03 · 2026-A00166-45