Status:
COMPLETED
Quality of Life Assessment Before and After Essure Removal
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
La Conception Hospital - Marseille - France
Public Assistance - Marseille Hospitals
Conditions:
Patients Presenting Essure Device Attributed Symptoms
Eligibility:
FEMALE
18+ years
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 ...
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 complicati...
Eligibility Criteria
Inclusion
- Patients carrying Essure®
- Patients requesting surgical removal of Essure®
- Patients with adverse effect
- Being affiliated or benefiting from a French social security system
Exclusion
- \- Patients with guardianship or curators
Key Trial Info
Start Date :
January 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2018
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03401437
Start Date
January 10 2017
End Date
November 16 2018
Last Update
January 4 2019
Active Locations (2)
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1
Public Assistance - Marseille Hospitals
Marseille, France, 13005
2
Montpellier University Hospital
Montpellier, France, 34295