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NCT Number: NCT07560852

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

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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Key information

Conditions

Patient With a Prescribed Endotest Disease Endometriosis Endometriosis (Diagnosis) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinique Tivoli Ducos, Bordeaux, Gironde, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. 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.

    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.

  2. 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

    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.

  3. To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.

    Time frame: 6 months

    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.

  4. To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.

    Time frame: 6 months

    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.

Secondary outcomes

  1. Describe the impact of Endotest on adaptation strategies.

    Time frame: 6 months

    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

  2. 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

    Number of patients starting an assisted reproductive technology (ART) treatment programme

  3. 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

    Number of patients for whom the ART treatment plan is amended (e.g. switching from intrauterine insemination to IVF, surgery)

  4. Describe the impact of Endotest's results immediately following the announcement.

    Time frame: 1 month

    Personalised questionnaire on immediate emotional reactions

  5. 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

    Number and type of additional tests or procedures performed (ultrasound, MRI, laparoscopy, etc.).

  6. 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

    Initiation or modification of treatments (hormonal, pain relievers, etc.).

  7. To assess the impact of Endotest on anxiety levels.

    Time frame: 1 month

    Visual Analog Scale Anxiety Score Score goes from 0 to 100 Lower the score is, better the outcome is

  8. Compare the care provided to patients with a positive Endotest result across participating countries.

    Time frame: Through study completion, an average of 1 year

    Type of coverage and waiting period

  9. Compare pelvic sensitivity based on Endotest results

    Time frame: Day 1 and 12 months

    Convergences Score for Pelvic-Perineal Pain Score goes from 0 to 10 Lower the score is, better the outcome is.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabien Le Floc'h, Project Manager

CONTACT

[email protected]

+330630447709

Sponsors and collaborators

Lead sponsor

ZIWIG

Industry

Collaborators

  • Monitoring Force Group

Registry information

Acronym: ENDOLIFE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 1, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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