Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

Completed

• Conditions: Contraceptive Device; Complications; Quality of Life

• Registration Number: NCT03623126
• Lead Sponsor: Hospices Civils de Lyon

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-06
• Study Start: 2018-08-08
• Study First Posted: 2018-08-09
• Primary Completion: 2018-09-03
• Study Completion: 2018-09-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

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

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Exclusion Criteria

• Women who underwent ESSURE removal to restore their fertility.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the clinical improvement after the intervention of withdrawal of ESSURE devices	One day at least one month after the procedure	This evaluation will be carried out thanks to a questionnaire. The 4th question retrospectively identifies the symptoms presented by patients. The proposed list of symptoms was established by reviewing the symptoms most often found in the medical records of the patients included.; Question 11 evaluates the variation of each symptom after removal of ESSURE devices through an ordinal scale (total disappearance, significant improvement, poor improvement, no improvement, worsening).

Trial Locations

Locations (2)

Service de Gynécologie-Obstétrique - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

Service de gynécologie-Obstétrique - Hôpital de la Croix Rousse; 🇫🇷 Lyon, France