RecruitingNCT07560852

Impact of Endotest on Patients' Quality of Life: a Cohort Study


Sponsor

ZIWIG

Enrollment

20,000 participants

Start Date

May 6, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 43 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

OTHERQuestionnaire

EHP 5+6, RAND-36 et 6 and 12 months follow-up visits


Locations(7)

Clinique Tivoli Ducos

Bordeaux, Gironde, France

Hôpital privé Saint-Grégoire

Saint-Grégoire, Ille-et-Vilaine, France

Groupe Hospitalier Bretagne Sud - GHBS - Lorient

Lorient, Morbihan, France

Hôpital de Mercy - CHR Metz Thionville

Peltre, Moselle, France

CHU de Saint Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, France

Centre Hospitalier de Pau

Pau, Pyrénées Atlantiques, France

Hôpital Jacques Monod - GH du Havre

Montivilliers, Seine-maritime, France

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NCT07560852


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