Trials / Completed
CompletedNCT03623126
Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 41 (actual)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-08-08
- Primary completion
- 2018-09-03
- Completion
- 2018-09-03
- First posted
- 2018-08-09
- Last updated
- 2019-05-13
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03623126. Inclusion in this directory is not an endorsement.