A Clinical Study to Evaluate the Safety and Effectiveness of the ESS505 Device to Prevent Pregnancy
A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505 Device to Prevent Pregnancy in Women Who are Seeking Permanent Contraception
-Evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS%)% device in preventing pregnancy.
TIMELINES -The duration of a subject's study participation will be approximately 12 months; the study period ends after completion of the 12-month telephone contact (total study participation not to exceed 12.5 months). The study will be considered complete when all subjects either complete the study period or withdraw early from study.
-The study is a prospective, multicentre, non-randomised, non-control, international study.
POPULATION -60 Subjects will be enrolled from up to six qualified clinical sites. Each site is invited to enroll approximately 10 subjects who satisfy study participation criteria. Enrollment period duration is anticipated to be 6 months.
- Subjects meeting eligibility requirements will be assessed and confirmed appropriate for ESS505 placement.
- Study sponsor is responsible for any costs related to the investigational device (ESS505), clinical procedures, testing, medications and follow up visits.
- Study related data will be recorded on case report forms.
- All serious adverse events will be recorded on the case report forms at each visit. Subjects will be encouraged to immediately report any AE occuring between visits to the sponsor.
-Safety analysis will be conducted on the safety analysis population, which includes all subjects in whom the ESS505 device was placed into the body.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception|
- Occurence of Pregnancy [ Time Frame: 3 months ] [ Designated as safety issue: No ]The primary endpoint to be evaluated in this study is occurrence of pregnancy at the 3 month visit in women told to relay on ESS505 for contraception. Absence of pregnancy is confirmed by a urine or blood pregnancy test.
- One Year Effectiveness Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]One year effectiveness rate; methods to calculate rates and confidence intervals will be identical to that described for the primary endpoint.
- Safety of the ESS505 Device Placement Procedure [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]Assess severity and frequency of reported adverse events related to device placement procedure
- Safety of Subsequent Wearing of the Device [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Assess severity and and frequency of adverse events reported among subjects in whom one or more ESS505 inserts are placed
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||October 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Device: ESS505 (BAY1454033)
Other Name: Essure System for Permanent Birth Control Model ESS505
This study has previously been posted by Conceptus, Inc. (US).
After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
|Hoofddorp, Netherlands, 2134 TM|
|Nieuwegein, Netherlands, 3435 CM|
|Tiel, Netherlands, 4002 WP|
|Zwolle, Netherlands, 8025 AB|
|Córdoba, Spain, 14004|
|Study Director:||Bayer Study Director||Bayer|