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

Bayer

Status: Completed

Conditions: Contraception

Treatments: Device: ESS305 (Essure, BAY1454032)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02510443

ES0810FR (Other Identifier)

18097

Details and patient eligibility

About

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.

Full description

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

Enrollment: 2,644 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,644 participants in 1 patient group

BAY1454032

Description:

All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure

Treatment:

Device: ESS305 (Essure, BAY1454032)