Patients Presenting Essure Device Attributed SymptomsESSURENCT03401437
Quality of Life Assessment Before and After Essure Removal
An observational study of Patients Presenting Essure Device Attributed Symptoms, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients Presenting Essure Device Attributed Symptoms
- What is being tested?
- SF-36, HAD and ANSM
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 95 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Jan 2017to 16 Nov 2018
- 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: Patient with definitive sterilization by Essure®
Who may be able to join
- Patients carrying Essure®
- Patients requesting surgical removal of Essure®
- Patients with adverse effect
- Being affiliated or benefiting from a French social security system
Who cannot join
- Patients with guardianship or curators
Trial locations and contacts
2 sites in 1 country.
France2 sites
Public Assistance - Marseille Hospitals
Marseille, 13005
Montpellier University Hospital
Montpellier, 34295
About this study
Official title: Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study
To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.
Read the detailed description
Tubal sterilization is a widely used method of contraception. The hysteroscopic sterilization method (Essure®; Bayer, Germany) was approved in 2007 in France. Increasing patients reports of complications, such as bleeding pain, allergies, fatigue or articular pain have raised concerns about the safety device. Women suffering of alleged complications of the Essure® device ask for surgical removal. But, only few studies have assessed Essure® removal in terms of quality of life. This observational study contains two parts will be conducted at two academic tertiary care center (Montpellier - Marseille):
- a prospective part having received a favorable opinion from a Committee for the Protection of Persons,
- and a retrospective part having received a favorable opinion from the Institutional Review Board (IRB), local ethics committee
Patients: Women requesting surgical management for removal of Essure® for alleged adverse effects.
Assessment tools :
Quality of life with the Short Form 36 (SF-36) Health Survey questionnaire (pre-operatively and at 1 and 3 months) Hospital Anxiety and Depression (HAD) scale (pre-operatively and 3 months)
Preoperative imaging, procedure characteristics, including the Essure® removal method, operative findings, perioperative complications, histopathologic report, and length of hospital stay will be collected.
- Being tested
- SF-36, HAD, ANSM
- Keywords
- adverse effects, Salpingectomy, Essure® device ablation, Cornual resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF-36Behavioural
Also called Short Form 36 Health Survey questionnaire
Evaluation of the quality of life with an auto-questionnaire validated, with 8 dimensions: physical activity ; limitations due to physical condition; physical pain; perceived health; vitality; life and relationship with others; limitations due to physical condition; psychic health as well as the assessment of perceived health compared to a year ago. Evaluation done pre-operatively, at M1 and M3
HADBehavioural
Also called Hospital Anxiety and Depression scale
Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.
ANSMOther
Also called ANSM questionnaire
Additional information requested by the ANSM (french National Agency for Medicines and Health Products Safety) following a materiovigilance report. Evaluation done pre-operatively and at M3.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohorte | Patients seen in consultation between January 2017 and August 2017, who have already completed the SF-36 questionnaire (pre-operative, M1 and M3), the HAD and ANSM questionnaires (pre-operative and M3) | |
| Prospective cohorte | Patients seen in consultation between August 2017 Receives: Behavioral: SF-36; Behavioral: HAD; Other: ANSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving the quality of life between pre and post-operative at 3 months
The quality of life is measure with Short Form (36) Health Survey Questionnaire
Measured: 3 months after the surgery
Secondary outcomes (5)
General disorders and anxiety or depression
General disorders and anxiety or depression (by questionnaire HAD)
Measured: One month before surgery and 3 months after surgery.
Performance of 3D ultrasound
Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively
Measured: Preoperatively
Allergy to components
Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests
Measured: Before removing the sterilization devices (Essure®)
Allergy to components
Reaction to metals: to estimate the prevalence of Nickel release by the Essure® , by the analysis of the surgical parts
Measured: During surgical removal
Defects in installation or secondary migration
Estimate the prevalence of Essure® deposition or secondary migration defects
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start10 Jan 2017
- Primary completion31 Jan 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Presenting Essure Device Attributed SymptomsStudies 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- La Conception Hospital - Marseille - France, Public Assistance - Marseille Hospitals, Aix Marseille Université
- Responsible party
- Sponsor
- Investigators
- PATRICE PC CROCHET, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401437
- Sponsor's protocol ID
- RECHMPL17_0154
- Acronym
- ESSURE
- Status last verified
- Jan 2019
- First submitted
- 26 Sep 2017
- Last updated
- 4 Jan 2019
- 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 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study
- ClinicalTrials.gov ID
- NCT03401437
- Acronym / sponsor ID
- ESSURE / RECHMPL17_0154
- Keywords
- adverse effects, Salpingectomy, Essure® device ablation, Cornual resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- La Conception Hospital - Marseille - France, Public Assistance - Marseille Hospitals, Aix Marseille Université
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 17 Jan 2018 (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.
To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.
Detailed description
Tubal sterilization is a widely used method of contraception. The hysteroscopic sterilization method (Essure®; Bayer, Germany) was approved in 2007 in France. Increasing patients reports of complications, such as bleeding pain, allergies, fatigue or articular pain have raised concerns about the safety device. Women suffering of alleged complications of the Essure® device ask for surgical removal. But, only few studies have assessed Essure® removal in terms of quality of life. This observational study contains two parts will be conducted at two academic tertiary care center (Montpellier - Marseille):
- a prospective part having received a favorable opinion from a Committee for the Protection of Persons,
- and a retrospective part having received a favorable opinion from the Institutional Review Board (IRB), local ethics committee
Patients: Women requesting surgical management for removal of Essure® for alleged adverse effects.
Assessment tools :
Quality of life with the Short Form 36 (SF-36) Health Survey questionnaire (pre-operatively and at 1 and 3 months) Hospital Anxiety and Depression (HAD) scale (pre-operatively and 3 months)
Preoperative imaging, procedure characteristics, including the Essure® removal method, operative findings, perioperative complications, histopathologic report, and length of hospital stay will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohorte | – | –Patients seen in consultation between January 2017 and August 2017, who have already completed the SF-36 questionnaire (pre-operative, M1 and M3), the HAD and ANSM questionnaires (pre-operative and M3) |
| Prospective cohorte | – | Behavioral: SF-36, Behavioral: HAD, Other: ANSMPatients seen in consultation between August 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with definitive sterilization by Essure®
Key inclusion criteria (4 listed)
- Patients carrying Essure®
- Patients requesting surgical removal of Essure®
- Patients with adverse effect
- Being affiliated or benefiting from a French social security system
Key exclusion criteria (1 listed)
- Patients with guardianship or curators
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 |
|---|---|---|
| SF-36Also: Short Form 36 Health Survey questionnaireEvaluation of the quality of life with an auto-questionnaire validated, with 8 dimensions: physical activity ; limitations due to physical condition; physical pain; perceived health; vitality; life and relationship with others; limitations due to physical condition; psychic health as well as the assessment of perceived health compared to a year ago. Evaluation done pre-operatively, at M1 and M3 | Behavioural | Prospective cohorte |
| HADAlso: Hospital Anxiety and Depression scaleEvaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3. | Behavioural | Prospective cohorte |
| ANSMAlso: ANSM questionnaireAdditional information requested by the ANSM (french National Agency for Medicines and Health Products Safety) following a materiovigilance report. Evaluation done pre-operatively and at M3. | Other | Prospective cohorte |
Primary outcome
Improving the quality of life between pre and post-operative at 3 months
Time frame: 3 months after the surgery
The quality of life is measure with Short Form (36) Health Survey Questionnaire
5 secondary outcomes
General disorders and anxiety or depression
Time frame: One month before surgery and 3 months after surgery.
Performance of 3D ultrasound
Time frame: Preoperatively
Allergy to components
Time frame: Before removing the sterilization devices (Essure®)
Allergy to components
Time frame: During surgical removal
Defects in installation or secondary migration
Time frame: during surgery
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 4 Jan 2019.
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.
PATRICE PC CROCHET, PhD study director
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Presenting Essure Device Attributed Symptoms, run by University Hospital, Montpellier at 2 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 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: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Improving the quality of life between pre and post-operative at 3 months (time frame: 3 months after the surgery). 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 4 Jan 2019.