ContraceptionESSURENCT04779658
Laparoscopic Essure Device Removal
An observational study of Contraception, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Dec 2021
- 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: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.
Who may be able to join
- age >18 years old
- symptoms related to ESSURE device
- salpingectomy for ESSURE removal
Who cannot join
- Exclusion criteria were failure to perform a complete removal of the Essure and second surgery to remove fragments left behind from a previous procedure.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
RATHAT GAUTHIER, MD, 467336421 ext. 33, g-rathat@chu-montpellier.fr
DURAES Martha, 631329158 ext. 33, duraesmartha@gmail.com
About this study
Official title: Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal
In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device.
Study Objective: To evaluate the quality of life of patients who underwent Essure_ device removal and morbidity of this surgery.
Read more
Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France.
Patients: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.
Methods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires.
Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.
- Conditions
- Contraception
- Keywords
- Essure device removal, Quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of quality of life after ESSURE removal
Evaluation of quality of life after ESSURE removal by SF 36 questionnaire Preoperative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up
Measured: Preoperative
Evaluation of quality of life after ESSURE removal
Evaluation of quality of life after ESSURE removal by SF 36 questionnaire three-months post-operative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up
Measured: three-months post-operative
Secondary outcomes (1)
Evaluation of morbidity of ESSURE removal
description of per et postoperative complications (patient's medical record and by phone call)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Jan 2021
- Primary completion29 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha DURAES, Md, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779658
- Sponsor's protocol ID
- RECHMPL21_0087
- Acronym
- ESSURE
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal
- ClinicalTrials.gov ID
- NCT04779658
- Acronym / sponsor ID
- ESSURE / RECHMPL21_0087
- Conditions
- Contraception
- Keywords
- Essure device removal, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 29 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 3 Mar 2021 (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.
In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device.
Study Objective: To evaluate the quality of life of patients who underwent Essure_ device removal and morbidity of this surgery.
Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France.
Patients: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.
Methods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires.
Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.
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
- Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.
Key inclusion criteria (3 listed)
- age >18 years old
- symptoms related to ESSURE device
- salpingectomy for ESSURE removal
Key exclusion criteria (1 listed)
- Exclusion criteria were failure to perform a complete removal of the Essure and second surgery to remove fragments left behind from a previous procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of quality of life after ESSURE removal
Time frame: Preoperative
Evaluation of quality of life after ESSURE removal by SF 36 questionnaire Preoperative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up
Evaluation of quality of life after ESSURE removal
Time frame: three-months post-operative
Evaluation of quality of life after ESSURE removal by SF 36 questionnaire three-months post-operative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up
1 secondary outcome
Evaluation of morbidity of ESSURE removal
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Martha DURAES, Md principal investigator
University Hospital, Montpellier
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 Contraception, run by University Hospital, Montpellier 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 1 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 3 Mar 2021. 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?
Contact GAUTHIER RATHAT (467336421 ext. 33, g-rathat@chu-montpllier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of quality of life after ESSURE removal (time frame: Preoperative). 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 3 Mar 2021.