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Quality of Life Assessment Before and After Essure Removal (ESSURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401437
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
La Conception Hospital - Marseille - France
Public Assistance - Marseille Hospitals
Aix Marseille University
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment
Patients Presenting Essure Device Attributed Symptoms Behavioral: SF-36 Behavioral: HAD Other: ANSM

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.


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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
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
Behavioral: SF-36
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
Other Name: Short Form 36 Health Survey questionnaire

Behavioral: HAD
Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.
Other Name: Hospital Anxiety and Depression scale

Other: ANSM
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.
Other Name: ANSM questionnaire




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. General disorders and anxiety or depression [ Time Frame: One month before surgery and 3 months after surgery. ]
    General disorders and anxiety or depression (by questionnaire HAD)

  2. Performance of 3D ultrasound [ Time Frame: Preoperatively ]
    Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively

  3. Allergy to components [ Time Frame: Before removing the sterilization devices (Essure®) ]
    Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests

  4. Allergy to components [ Time Frame: During surgical removal ]
    Reaction to metals: to estimate the prevalence of Nickel release by the Essure® , by the analysis of the surgical parts

  5. Defects in installation or secondary migration [ Time Frame: during surgery ]
    Estimate the prevalence of Essure® deposition or secondary migration defects



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with definitive sterilization by Essure®
Criteria

Inclusion Criteria:

  • Patients carrying Essure®
  • Patients requesting surgical removal of Essure®
  • Patients with adverse effect
  • Being affiliated or benefiting from a French social security system

Exclusion Criteria:

- Patients with guardianship or curators


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401437


Locations
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France
Public Assistance - Marseille Hospitals
Marseille, France, 13005
Montpellier University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
La Conception Hospital - Marseille - France
Public Assistance - Marseille Hospitals
Aix Marseille University
Investigators
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Study Director: PATRICE PC CROCHET, PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03401437     History of Changes
Other Study ID Numbers: RECHMPL17_0154
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
adverse effects
Salpingectomy
Essure® device ablation
Cornual resection