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Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

NCT03623126 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2019-05-13

No results posted yet for this study

Summary

The ESSURE device is a method of permanent contraception, marketed in France since 2005. Multiple side effects have been reported by patients since 2015 and the marketing was stopped in 2017. For several months it was observed an increase in requests for withdrawal of these devices. The principal objective of this study is to evaluate clinical improvement and quality of life after ESSURE removal.

This is a multicenter retrospective descriptive study involving the gynecology department of the Croix Rousse Hospital and the gynecology department of the Lyon Sud Hospital over a period of 1 year (1 January 2017-31 December 2017).

Conditions

  • Quality of Life
  • Contraceptive Device; Complications

Interventions

OTHER

Questionnaire

A questionnaire to evaluate clinical improvement and quality of life after ESSURE removal will be completed by patients at least one month after the procedure.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2018-09-03
Completion
2018-09-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623126 on ClinicalTrials.gov