Endometriosis, AdhesiveENDHYNCT02612818
Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year
An observational study of Endometriosis, Adhesive, run by Nordic Pharma SAS at 1 site in France.
Trial summary
Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Adhesive
- What is being tested?
- Coelioscopy
- Type of treatment
- Medical device
- How many people
- 364 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2015to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subsequent patients of procreation age having undergone a cœlioscopy for endometriosis, for whom a spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately, and meeting all of the selection criteria will be included in the study.
Who may be able to join
- Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery.
- Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately.
- Patients accepting and able to update a questionnaire in French.
- Informed patients who agree to computerised processing of their medical data and their right of access and rectification.
Who cannot join
- Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress.
- Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc).
- Patients not wishing to become pregnant.
- Patients participating or having participated during the previous month in a gynaecological clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.
The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.
- Conditions
- Endometriosis, Adhesive
- Being tested
- Coelioscopy
- Keywords
- coelioscopy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoelioscopyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the clinical signs
The clinical change will be established after one year via the pain symptomatology reported by the patient, the rate of relapse (re-hospitalisation) and the rate of any eventual complications from the celioscopy (adhesions, etc.).
Measured: At 2 months and one year after the baseline visit (i.e. celioscopy)
Fertility
rate of pregnancy women
Measured: One year after the baseline visit (i.e. celioscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start24 Nov 2015
- Primary completionJul 2018
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis, AdhesiveStudies 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
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hélène HERMAN-DEMARS, MD, Study director, Nordic Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612818
- Sponsor's protocol ID
- ENDHY
- Acronym
- ENDHY
- Status last verified
- Jul 2017
- First submitted
- 20 Nov 2015
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year
- ClinicalTrials.gov ID
- NCT02612818
- Acronym / sponsor ID
- ENDHY / ENDHY
- Conditions
- Endometriosis, Adhesive
- Keywords
- coelioscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Nordic Pharma SASIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- May 2019 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- 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.
Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.
The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subsequent patients of procreation age having undergone a cœlioscopy for endometriosis, for whom a spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately, and meeting all of the selection criteria will be included in the study.
Key inclusion criteria (4 listed)
- Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery.
- Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately.
- Patients accepting and able to update a questionnaire in French.
- Informed patients who agree to computerised processing of their medical data and their right of access and rectification.
Key exclusion criteria (4 listed)
- Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress.
- Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc).
- Patients not wishing to become pregnant.
- Patients participating or having participated during the previous month in a gynaecological clinical trial.
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 |
|---|---|---|
| Coelioscopy | Device | – |
Primary outcome
Change on the clinical signs
Time frame: At 2 months and one year after the baseline visit (i.e. celioscopy)
The clinical change will be established after one year via the pain symptomatology reported by the patient, the rate of relapse (re-hospitalisation) and the rate of any eventual complications from the celioscopy (adhesions, etc.).
Fertility
Time frame: One year after the baseline visit (i.e. celioscopy)
rate of pregnancy women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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. This study is not recruiting at the moment.
Hélène HERMAN-DEMARS, MD study director
Nordic Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, Adhesive, run by Nordic Pharma SAS at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the clinical signs (time frame: At 2 months and one year after the baseline visit (i.e. celioscopy)). The study lists 2 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 1 Aug 2018.