Last updated on February 2019

Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure ) or Laparoscopic Tubal Sterilization

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Contraception
  • Age: Between 21 - 45 Years
  • Gender: Female

Inclusion Criteria:

  • Subjects who are 21 to 45 years of age;
  • Subjects who are between 90 and 300 pounds;
  • Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.
  • For the Essure group only:

Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;

  • For the laparoscopic tubal sterilization group only:
  • Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.

Exclusion Criteria:

  • Subjects who are post-menopausal;
  • Subjects suspected of being or confirmed pregnant;
  • Subjects post-partum or undergone pregnancy termination 6 weeks prior to scheduled procedure;
  • Subjects uncertain about ending fertility;
  • Subjects with an active upper or lower genital tract infection;
  • Subjects with gynecologic malignancy (suspected or known);
  • Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic);
  • Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization;
  • Subjects with unexplained vaginal bleeding.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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