Observational Study on Contraception With Essure in France

Contraception Clinical Trial

— SUCCES II  

Official title:

Survey on Use and Characteristics of Definitive Contraception With ESsure®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510443
• Other study ID #: 18097
• Secondary ID: ES0810FR
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: September 12, 2017
• Start date: June 23, 2008
• Est. completion date: November 25, 2016

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2644
• Est. completion date: November 25, 2016
• Est. primary completion date: September 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• ESS305 (Essure, BAY1454032)
Bilateral insert placement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Hôpital André Mignot Centre Hospitalier de Versailles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients being satisfied with successful Essure procedure having no complications 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	Number of patients with moderate or important pain when placement is performed	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
Secondary	Number of unsatisfied patients		Up to 5 years
Secondary	Number of satisfied patients at 3, 12 and 24 months	Patients satisfaction assessed by Likert scale.	At 3 ,12 and 24 months
Secondary	Number of examinations by patients		At 3 months
Secondary	Number of good insert position by implant and patients with success in final result of the procedure		At 3 months
Secondary	Causes of unsatisfied patients	Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection	Up to 5 years
Secondary	Type of examinations by patients	Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)	At 3 months
Secondary	Number of patients with regrets		At 12 months, 24 months and 5 years

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