Inflammatory DiseaseESCYTONCT05944822
Pro-inflammatory Cytokines in Case of Essure®
An observational study of Inflammatory Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Inflammatory Disease
- What is being tested?
- pro-inflammatory cytokines
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to 30 Dec 2023
- 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: This study focuses on patients who underwent surgery to remove the Essure® contraceptive implant and on control patients who underwent benign gynecological laparoscopic surgery.
Who may be able to join
- women over 18
- intervention between January 2021 and November 2022
- person having expressed his non-opposition
- Essure group : patient who underwent removal of the Essure® contraceptive implant
- Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
- Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis
Who cannot join
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
Bron, 69500
About this study
Official title: Study of Pro-inflammatory Cytokines in Case of Essure® Contraceptive Implants
It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.
The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.
Read more
Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.
The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.
- Conditions
- Inflammatory Disease
- Being tested
- pro-inflammatory cytokines
- Keywords
- contraceptive implants, pro-inflammatory cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pro-inflammatory cytokinesOther
compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.
| Study group | Role | What they receive |
|---|---|---|
| Essure | patient who underwent removal of the Essure® contraceptive implant Receives: Other: pro-inflammatory cytokines | |
| Control with no endometriosis/adenomyosis | patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis Receives: Other: pro-inflammatory cytokines | |
| Control with endometriosis/adenomyosis | patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis Receives: Other: pro-inflammatory cytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine IL10 in peritoneal fluid
Level of cytokine IL10 in peritoneal fluid
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Nov 2022
- Primary completion31 Jul 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944822
- Sponsor's protocol ID
- 69HCL23_0557
- Acronym
- ESCYTO
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pro-inflammatory Cytokines in Case of Essure® Contraceptive Implants
- ClinicalTrials.gov ID
- NCT05944822
- Acronym / sponsor ID
- ESCYTO / 69HCL23_0557
- Conditions
- Inflammatory Disease
- Keywords
- contraceptive implants, pro-inflammatory cytokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Jul 2023 (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.
It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.
The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.
Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.
The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Essure | – | Other: pro-inflammatory cytokinespatient who underwent removal of the Essure® contraceptive implant |
| Control with no endometriosis/adenomyosis | – | Other: pro-inflammatory cytokinespatient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis |
| Control with endometriosis/adenomyosis | – | Other: pro-inflammatory cytokinespatient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study focuses on patients who underwent surgery to remove the Essure® contraceptive implant and on control patients who underwent benign gynecological laparoscopic surgery.
Key inclusion criteria (6 listed)
- women over 18
- intervention between January 2021 and November 2022
- person having expressed his non-opposition
- Essure group : patient who underwent removal of the Essure® contraceptive implant
- Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
Key exclusion criteria (3 listed)
- inability to understand the information given
- person deprived of liberty
- person under guardianship
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 |
|---|---|---|
| pro-inflammatory cytokinescompare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis. | Other | Control with endometriosis/adenomyosis, Control with no endometriosis/adenomyosis, Essure |
Primary outcome
cytokine IL10 in peritoneal fluid
Time frame: through study completion, an average of 4 months
Level of cytokine IL10 in peritoneal fluid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Disease, run by Hospices Civils de Lyon 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 6 inclusion and 3 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 13 Nov 2023. 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?
cytokine IL10 in peritoneal fluid (time frame: through study completion, an average of 4 months). 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 13 Nov 2023.