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

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

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Device: ESS505 (BAY1454033)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESS505<br>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. | Device: ESS505 (BAY1454033)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception |  | 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. | 3 months | 
| Severity of reported ESS505 placement procedure-related AEs | 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014 | 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 | 3 months | 
| Severity of reported ESS505 wearing-related AEs | 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth control, Permanent Contraception