Contraceptive Device; ComplicationsABLIMCONCT03281564
Quality of Life After Laparoscopic Removal of Essure®
An observational study of Contraceptive Device; Complications and Quality of Life, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraceptive Device; Complications, Quality of Life
- What is being tested?
- Quality of life after Essure® removal
- How many people
- 474 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2017to 17 Oct 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: Patients with laparoscopic removal of Essure®
Who may be able to join
- women aged 18 years or more
- patients with Essure® sterilization device
- surgical removal of Essure® with bilateral salpingectomy by laparoscopy
Who cannot join
- interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- impaired lower-limb range of motion preventing positioning for surgery
- inability to understand information provided
- prisoner or under administrative supervision.
Trial locations and contacts
1 site in 1 country.
France1 site
Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69677
About this study
Official title: Prospective Study of Quality of Life After Laparoscopic Removal of Essure®
A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.
- Being tested
- Quality of life after Essure® removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life after Essure® removalOther
Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device
| Study group | Role | What they receive |
|---|---|---|
| Essure® | Patients with laparoscopic removal of Essure® Receives: Other: Quality of life after Essure® removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life 1 month after laparoscopic removal of Essure®
Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start14 Oct 2017
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive Device; ComplicationsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 474 participants (actual)
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
- NCT03281564
- Sponsor's protocol ID
- 69HCL17_0479
- Acronym
- ABLIMCO
- Status last verified
- May 2023
- First submitted
- 11 Sep 2017
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trecourt A, Devouassoux-Shisheboran M, Nohuz E, Cerruto E, Moret S, Hallez D, Miguet-Bensouda C, Chene G. Clinical and histopathological correlations in symptomatic patients with salpingectomy for Essure(R) implant removal: a cross-sectional study. Eur J Contracept Reprod Health Care. 2023 Aug;28(4):227-233. doi: 10.1080/13625187.2023.2218953. Epub 2023 Jun 27.
PubMed 37365993
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
- Prospective Study of Quality of Life After Laparoscopic Removal of Essure®
- ClinicalTrials.gov ID
- NCT03281564
- Acronym / sponsor ID
- ABLIMCO / 69HCL17_0479
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 13 Sep 2017 (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.
A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essure® | – | Other: Quality of life after Essure® removalPatients with laparoscopic removal of Essure® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with laparoscopic removal of Essure®
Key inclusion criteria (3 listed)
- women aged 18 years or more
- patients with Essure® sterilization device
- surgical removal of Essure® with bilateral salpingectomy by laparoscopy
Key exclusion criteria (4 listed)
- interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- impaired lower-limb range of motion preventing positioning for surgery
- inability to understand information provided
- prisoner or under administrative supervision.
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 |
|---|---|---|
| Quality of life after Essure® removalQuestionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device | Other | Essure® |
Primary outcome
Quality of life 1 month after laparoscopic removal of Essure®
Time frame: 1 month
Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 37365993Trecourt A, Devouassoux-Shisheboran M, Nohuz E, Cerruto E, Moret S, Hallez D, Miguet-Bensouda C, Chene G. Clinical and histopathological correlations in symptomatic patients with salpingectomy for Essure(R) implant removal: a cross-sectional study. Eur J Contracept Reprod Health Care. 2023 Aug;28(4):227-233. doi: 10.1080/13625187.2023.2218953. Epub 2023 Jun 27.
- 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 Contraceptive Device; Complications and Quality of Life, 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 3 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life 1 month after laparoscopic removal of Essure® (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281564, which also lists 1 linked publication.
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.