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Completed

NCT Number: NCT01948882

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

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.

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Key information

Conditions

Contraception

Age range

21 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESS505 (BAY1454033)

Device

Primary outcomes

  1. Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception

    Time frame: 1 year

    Evaluated after 6000 women-months of reliance have been accumulated

  2. 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

    Time frame: 3 months

    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)

Secondary outcomes

  1. Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception

    Time frame: 10 years

  2. 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

    Time frame: On day of placement procedure

  3. 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

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2024
First posted
Sep 24, 2013
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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