Observational Study on Contraception With Essure in France (SUCCES II)

September 12, 2017 updated by: Bayer

Survey on Use and Characteristics of Definitive Contraception With ESsure®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

2644

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The patients concerned are adult women wishing to undergo tubal sterilization for contraceptive purposes, in accordance with legal provisions, who had given their consent for collection of the data.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BAY1454032
All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure
Device: ESS305 (Essure, BAY1454032)
Bilateral insert placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At initial visit
Number of unsatisfied patients
Time Frame: Up to 5 years
Up to 5 years
Number of satisfied patients at 3, 12 and 24 months
Time Frame: At 3 ,12 and 24 months
Patients satisfaction assessed by Likert scale.
At 3 ,12 and 24 months
Number of examinations by patients
Time Frame: At 3 months
At 3 months
Number of good insert position by implant and patients with success in final result of the procedure
Time Frame: At 3 months
At 3 months
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
Up to 5 years
Type of examinations by patients
Time Frame: At 3 months
Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)
At 3 months
Number of patients with regrets
Time Frame: At 12 months, 24 months and 5 years
At 12 months, 24 months and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Hôpital André Mignot Centre Hospitalier de Versailles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2008

Primary Completion (Actual)

September 29, 2016

Study Completion (Actual)

November 25, 2016

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18097
  • ES0810FR (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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