Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

NCT03623126 | Completed

• 1 other identifier: 69HCL18_0160
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

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).

Conditions

Quality of Life; Contraceptive Device; Complications

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent ESSURE removal between January 2017 and January 2018 in the gynecology department of the Croix Rousse Hospital and the gynecology department of the Lyon Sud Hospital. .

You may qualify if:

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

You may not qualify if:

• \- Women who underwent ESSURE removal to restore their fertility.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service de gynécologie-Obstétrique - Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Service de Gynécologie-Obstétrique - Centre Hospitalier Lyon Sud

Pierre-Bénite, 60495, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: August 8, 2018
• Primary Completion: September 3, 2018
• Study Completion: September 3, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)