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

Bayer

Status: Completed

Conditions: Contraception

Treatments: Device: ESS505 (BAY1454033)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01948882

16973

Details and patient eligibility

About

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.

Enrollment: 660 patients

Sex: Female

Ages: 21 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

660 participants in 1 patient group

ESS505

Experimental group

Description:

All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.

Treatment:

Device: ESS505 (BAY1454033)