Overview

This trial is active, not recruiting.

Condition contraception
Treatment ess305 (bay1454033)
Sponsor Bayer
Start date June 2008
End date September 2016
Trial size 2644 participants
Trial identifier NCT02510443, 18097, ES0810FR

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All subjects who sign the informed consent and meet the eligibility criteria will be scheduled for an insert placement procedure
ess305 (bay1454033)
Bilateral insert placement

Primary Outcomes

Measure
Number of patients being satisfied with successful Essure procedure having no complications at 5 years
time frame: At 5 years

Secondary Outcomes

Measure
Number of patients with moderate or important pain when placement is performed without anesthesia
time frame: At initial visit
Number of unsatisfied patients
time frame: Up to 5 years
Number of satisfied patients at 3, 12 and 24 months
time frame: At 3 ,12 and 24 months
Number of examinations by patients
time frame: 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
Causes of unsatisfied patients
time frame: Up to 5 years
Type of examinations by patients
time frame: At 3 months

Eligibility Criteria

Female participants at least 18 years old.

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 written, informed consent. Exclusion Criteria: - Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.

Additional Information

Official title Survey on Use and Characteristics of Definitive Contraception With ESsure®
Description The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.