ESS505 Pre-hysterectomy Protocol

ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study

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.

This study has previously been posted by Conceptus, Inc. (US).

After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.

Inclusion Criteria:

• Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH), Total Vaginal Hysterectomy (TVH), Total Laparoscopic Hysterectomy (TLH) with Bilateral Total Salpingectomy or Bilateral Salpingo-oophorectomy (BSO), or Laparoscopic Supracervical Hysterectomy (LSH)
• Subjects who are 18 years of age and older
• Subjects who are able and willing to provide written informed consent
• Subjects who agree to use a contraceptive method following Essure placement until the hysterectomy procedure

Exclusion Criteria:

• Subjects with bilateral proximal tubal occlusion
• Subjects who have undergone fallopian tube sterilization
• Subjects with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia
• Subjects who are post-menopausal
• Subjects with pelvic inflammatory disease (PID)
• Subjects with gynecologic malignancy
• Pregnancy or suspected pregnancy
• Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement
• Known allergy to contrast media
• Any general health condition that may represent, in the opinion of the Investigator, an increased potential risk associated with participation