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Completed

NCT Number: NCT02510443

Observational Study on Contraception With Essure in France

Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Le Chesnay, 78150, France

About this study

The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Woman ≥ 18 years old,
  • Scheduled for Essure procedure
  • Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.

Exclusion criteria

  • Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.

Treatment and study plan

ESS305 (Essure, BAY1454032)

Device

Bilateral insert placement

Primary outcomes

  1. Number of patients being satisfied with successful Essure procedure having no complications at 5 years

    Time frame: At 5 years

    Patient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point.

Secondary outcomes

  1. Number of patients with moderate or important pain when placement is performed

    Time frame: At initial visit

    Visual Analogue Scale (VAS) use to report the pain from 0 (no pain) to 10 (maximal pain). Moderate pain will range from 4 to 6 and important pain will range from 7 to 10 on the VAS.

  2. Number of unsatisfied patients

    Time frame: Up to 5 years

  3. Number of satisfied patients at 3, 12 and 24 months

    Time frame: At 3 ,12 and 24 months

    Patients satisfaction assessed by Likert scale.

  4. Number of examinations by patients

    Time frame: At 3 months

  5. Number of good insert position by implant and patients with success in final result of the procedure

    Time frame: At 3 months

  6. Causes of unsatisfied patients

    Time frame: Up to 5 years

    Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection

  7. Type of examinations by patients

    Time frame: At 3 months

    Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)

  8. Number of patients with regrets

    Time frame: At 12 months, 24 months and 5 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Hôpital André Mignot Centre Hospitalier de Versailles

Registry information

Official study title

Survey on Use and Characteristics of Definitive Contraception With ESsure®

Acronym: SUCCES II

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2015
Registry last updated
Sep 13, 2017

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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