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

Bayer0 sites73 target enrollmentJanuary 31, 2013

ConditionsContraception

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Contraception
Sponsor: Bayer
Enrollment: 73
Primary Endpoint: Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.

Detailed Description

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Registry

clinicaltrials.gov

Start Date

January 31, 2013

End Date

September 30, 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female with age range 21 to 44 years
•Subjects who are seeking permanent contraception
•Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds)
•Subjects willing to accept the risk of pregnancy occurring while relying solely on the ESS505 as contraception
•Subjects for whom medical history and physical examination indicates bilateral viable and patent fallopian tubes
•Subjects who are able to comply with the protocol required follow-up visits (e.g., 3 month clinic visit, and the 12-month telephone interview)
•Subjects who provide written informed consent prior to enrolment
•Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding her experience wearing the device
•Subjects agrees that her anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies
•Subjects for whom there are no contraindications for use as described in the ESS505 Instructions for Use (IFU)

Exclusion Criteria

•Subjects with known proximal tubal occlusion in either fallopian tube
•Subjects who have undergone fallopian tube sterilization procedure
•Subjects diagnosed with unicornuate uterus
•Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assessment
•Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure
•Subjects suspected of being or confirmed pregnant
•Subjects post-partum or has undergone pregnancy termination ≤6 weeks of scheduled ESS505 placement
•Subjects diagnosed with active upper or lower pelvic infection
•Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU
•Subjects have positive pre-procedure pregnancy test

Outcomes

Primary Outcomes

Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.

Time Frame: 3 months

Secondary Outcomes

Frequency (number) of reported ESS505 placement procedure-related AEs(3 months)
Severity of reported ESS505 placement procedure-related AEs(3 months)
Frequency (number) of reported ESS505 (device) wearing-related AEs(3 months)
Severity of reported ESS505 wearing-related AEs(3 months)
Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception(12 months)