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OpenTrials
Completed

NCT Number: NCT03955822

Essure Permanent Birth Control, Effectiveness and Safety: A French Survey

Since 2002, in CHU Amiens, Essure implants started to be used for women in need of voluntary sterilization in accordance with French national recommendations. Recently patient committees emerged to alert health agency and governments about various symptoms possibly link to the Essure implants. New studies have been launched in order to determinate if Essure implants were involved with the symptoms described. According to the scientific literature no solid link between Essure and the symptomatology was highlighted. French National College of Gynecologists and Obstetricians send a letter of information for patient and gynecologists. French National agency of medicament suspended Essure authorization in august 2017 for 3 months. Bayer industry decided to withdraw from the market the Essure implants in autumn 2017. Currently Essure procedures have been stopped to be used in CHU Amiens since august 2017. But, in CHU Amiens, health institutions still have to manage patients with Essure implants and potential adverse effects.

The purpose of this study is to determine if the patients treated between 2002 and 2017 with Essure implant present complications, had a proper follow up after the Essure implantation, and that the Essure implantation respected the medical guidelines in order to offer the best medical care with these new informations.

Medical data from patients who received Essure procedure will be collected with medical file and a survey about adverse effects will be submitted to patients by phone if they agree to take part of the study after loyal information.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women more than 18 years old
  • patients who benefit of Essure permanent birth control in CHU Amiens between 2002 and 2017
  • signed informed consent form

Exclusion criteria

  • women Under 18 years old
  • refusal to participate
  • patient Under administrative supervision

Treatment and study plan

phone survey

Other

Phone Survey in order to evaluate adverse effect of the permanently implanted birth control device for women (Essure) will be proposed to wmen Treated between 2002 and 2017 with Essure.

Primary outcomes

  1. Number of side effects of Essure system for the patient

    Time frame: patients who benefited of Essure implant between 2002 and 2017

    this outcome is evaluated with data of medical files and with a phone survey submitted to the patient who had the essure procedure in CHU Amiens.

Secondary outcomes

  1. Number of patients who underwent Essure implant withdrawal

    Time frame: between 2002 and day of patient inclusion

    this outcome is evaluated with data of medical files and with a phone survey

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: prevessure

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 20, 2019
Registry last updated
Jul 16, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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