Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

Quality of Life Clinical Trial

— ESSURE  

Official title:

Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623126
• Other study ID #: 69HCL18_0160
• Status: Completed
• Start date: August 8, 2018
• Est. completion date: September 3, 2018

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 3, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraceptive Device; Complications
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
France	Service de gynécologie-Obstétrique - Hôpital de la Croix Rousse	Lyon
France	Service de Gynécologie-Obstétrique - Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the clinical improvement after the intervention of withdrawal of ESSURE devices	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).	One day at least one month after the procedure