To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
73
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.
Unnamed facility
Hoofddorp, Netherlands
Unnamed facility
Nieuwegein, Netherlands
Unnamed facility
Tiel, Netherlands
Unnamed facility
Zwolle, Netherlands
Unnamed facility
Córdoba, Córdoba, Spain
Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
Time frame: 3 months
Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception
Time frame: 12 months
Frequency (number) of reported ESS505 placement procedure-related AEs
Date of enrollment, 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014.
Time frame: 3 months
Severity of reported ESS505 placement procedure-related AEs
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Time frame: 3 months
Frequency (number) of reported ESS505 (device) wearing-related AEs
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Time frame: 3 months
Severity of reported ESS505 wearing-related AEs
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.