ESS505 Pre-hysterectomy Protocol
This study has been designed to evaluate an investigational model of the Essure System for Permanent Birth Control. The investigational device is designed to offer all the advantages of the currently approved device. In addition, the investigational device offers immediate, permanent contraception without a three-month waiting period or 90-day confirmation test. This study has been designed to evaluate the effectiveness of the investigational device in causing tubal occlusion from insert placement through three months of wearing.
Device: ESS505 (BAY1454033)
Device: ESS305 (Essure, BAY1454032)
Device: ESS505-A (Essure, BAY1454033)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study|
- Ability of the insert to occlude the fallopian tube [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Experimental: Investigational (ESS505) / Control Device (ESS305)||Device: ESS505 (BAY1454033) Device: ESS305 (Essure, BAY1454032)|
|Experimental: Investigational (ESS505-A)||Device: ESS505 (BAY1454033) Device: ESS505-A (Essure, BAY1454033)|
This study has previously been posted by Conceptus, Inc. (US).
After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664052
|Regina, Saskatchewan, Canada, S4P 0W5|
|Chihuahua, Mexico, 31350|
|Study Director:||Bayer Study Director||Bayer|