Evaluation of 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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The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.

Official Title
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A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model 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, 21 to 44 years of age, inclusive Body weight within range of 90-300 lbs (40 - 136 kg) Sexually active (minimum of 4 coital acts per cycle) Willing to accept the risk of pregnancy while relying solely on the inserts for contraception Medical history indicates bilateral viable and patent fallopian tubes Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods Exclusion Criteria: Post-menopausal woman Suspected or confirmed pregnancy Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement Past fallopian tube sterilization procedure and/or total or partial salpingectomies Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy Currently taking corticosteroids Known allergy to all contrast media available for use in hysterosalpingogram Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy

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>All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure. | Device: ESS505 (BAY1454033)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception | Evaluated after 6000 women-months of reliance have been accumulated | 1 year | 
| Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted | Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception |  | 10 years | 
| Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube |  | On day of placement procedure | 
| Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed |  | Up to 10 years | 

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