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Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Contraceptive Device; Complications
Quality of Life

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT03623126
69HCL18_0160

Details and patient eligibility

About

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).

Enrollment

41 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women who underwent ESSURE removal due to suspected adverse effects of the device.
  • Women who agreed to participate in the study

Exclusion criteria

  • Women who underwent ESSURE removal to restore their fertility.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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