Patient With a Prescribed EndotestENDOLIFENCT07560852
Impact of Endotest on Patients' Quality of Life: a Cohort Study
An observational study of Patient With a Prescribed Endotest and Endometriosis (Diagnosis), run by ZIWIG at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Patient With a Prescribed Endotest, Endometriosis (Diagnosis)
- What is being tested?
- Questionnaire
- How many people
- 20,000 participants
- Where
- 7 sitesFrance
- Study dates
- 6 May 2026to 31 Jul 2029
- How long will I take part?
- 16 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Patient with endometriosis for whom an Endotest is prescribed
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Clinique Tivoli Ducos
Bordeaux, Gironde, 33000
Horace ROMAN, Physician, +330677651269, horace.roman@gmail.com
- Not yet recruiting
Groupe Hospitalier Bretagne Sud - GHBS - Lorient
Lorient, Morbihan, 56100
Antoine SCATTARELLI, Physician, +330297067437, a.scattarelli@ghbs.bzh
- Not yet recruiting
Hôpital Jacques Monod - GH du Havre
Montivilliers, Seine-maritime, 76290
Adnene TRIMECH, Physician, +330621581730, agnene.trimech@ch-havre.fr
- Not yet recruiting
Centre Hospitalier de Pau
Pau, Pyrénées Atlantiques, 64000
Aurélie CHIROL, Physician, +330559726998, aurelie.chirol@ch-pau.fr
- Not yet recruiting
Hôpital de Mercy - CHR Metz Thionville
Peltre, Moselle, 57245
Laurianne BOUSCHBACHER, Physician, +330387186426, laurianne.bouschbacher@chr-metz-thionville.fr
- Not yet recruiting
Hôpital privé Saint-Grégoire
Saint-Grégoire, Ille-et-Vilaine, 35760
Sophie LORAND, Physician, +330299239368, slorand@vivalto-sante.com
- Not yet recruiting
CHU de Saint Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270
Céline CHAULEUR, Physician, +330477828383, celine.chauleur@chu-st-etienne.fr
About this 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.
- Being tested
- Questionnaire
- Keywords
- endometriosis
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
EHP 5+6, RAND-36 et 6 and 12 months follow-up visits
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis cohort performing Ziwig ENDOTEST® | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (9)
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
Measured: 6 months
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
Measured: 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)
Measured: 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
Measured: 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.).
Measured: 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.).
Measured: 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
Measured: 1 month
Compare the care provided to patients with a positive Endotest result across participating countries.
Type of coverage and waiting period
Measured: 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.
Measured: Day 1 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start6 May 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With a Prescribed EndotestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- ZIWIG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560852
- Sponsor's protocol ID
- 2025ZW03
- Other IDs
- 2026-A00166-45
- Acronym
- ENDOLIFE
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endotest on Patients' Quality of Life: a Cohort Study
- ClinicalTrials.gov ID
- NCT07560852
- Acronym / sponsor ID
- ENDOLIFE / 2025ZW03
- Keywords
- endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- ZIWIGIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Study start
- 6 May 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis cohort performing Ziwig ENDOTEST® | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient with endometriosis for whom an Endotest is prescribed
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Contraindications for the use of Endotest:
- Significant difficulty reading and understanding the language of the country in which the participant is located.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireEHP 5+6, RAND-36 et 6 and 12 months follow-up visits | Other | Endometriosis cohort performing Ziwig ENDOTEST® |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient With a Prescribed Endotest and Endometriosis (Diagnosis), run by ZIWIG at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabien Le Floc'h, Project Manager (+330630447709, fabien.lefloch@monitoring-force.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.