Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03623126
• Collaborator: (none)
• Enrollment: 41
• Locations: 2
• Actual Duration (Days): 26
• Patients Per Site: 20.5
• Patients Per Site Per Month: 24

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Contraceptive Device; Complications	Other: Questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 41 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients
• Actual Study Start Date: Aug 8, 2018
• Actual Primary Completion Date: Sep 3, 2018
• Actual Study Completion Date: Sep 3, 2018

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de gynécologie-Obstétrique - Hôpital de la Croix Rousse	Lyon		France	69004
2	Service de Gynécologie-Obstétrique - Centre Hospitalier Lyon Sud	Pierre-Bénite		France	60495

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT03623126
• Other Study ID Numbers: 69HCL18_0160
• First Posted: Aug 9, 2018
• Last Update Posted: May 13, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 13, 2019