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Completed

NCT Number: NCT03623126

Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

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).

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Key information

Conditions

Quality of Life Contraceptive Device; Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of the clinical improvement after the intervention of withdrawal of ESSURE devices

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ESSURE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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