The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

NACompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 19, 2013

Study Completion Date

September 30, 2014

Conditions
Contraception
Interventions
DEVICE

ESS505 (BAY1454033)

Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement.

Trial Locations (5)

14004

Córdoba

2134 TM

Hoofddorp

3435 CM

Nieuwegein

4002 WP

Tiel

8025 AB

Zwolle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY