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Completed

NCT Number: NCT01861886

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

To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.

Completed

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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

Hoofddorp, Netherlands

Loading trial locations.

About this study

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female with age range 21 to 44 years
  • Subjects who are seeking permanent contraception
  • Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds)
  • Subjects willing to accept the risk of pregnancy occurring while relying solely on the ESS505 as contraception
  • Subjects for whom medical history and physical examination indicates bilateral viable and patent fallopian tubes
  • Subjects who are able to comply with the protocol required follow-up visits (e.g., 3 month clinic visit, and the 12-month telephone interview)
  • Subjects who provide written informed consent prior to enrolment
  • Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding her experience wearing the device
  • Subjects agrees that her anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies
  • Subjects for whom there are no contraindications for use as described in the ESS505 Instructions for Use (IFU)

Exclusion criteria

  • Subjects with known proximal tubal occlusion in either fallopian tube
  • Subjects who have undergone fallopian tube sterilization procedure
  • Subjects diagnosed with unicornuate uterus
  • Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assessment
  • Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure
  • Subjects suspected of being or confirmed pregnant
  • Subjects post-partum or has undergone pregnancy termination ≤6 weeks of scheduled ESS505 placement
  • Subjects diagnosed with active upper or lower pelvic infection
  • Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU
  • Subjects have positive pre-procedure pregnancy test

Treatment and study plan

ESS505 (BAY1454033)

Device

Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement.

Primary outcomes

  1. Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.

    Time frame: 3 months

Secondary outcomes

  1. Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception

    Time frame: 12 months

  2. Frequency (number) of reported ESS505 placement procedure-related AEs

    Time frame: 3 months

    Date of enrollment, 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014.

  3. Severity of reported ESS505 placement procedure-related AEs

    Time frame: 3 months

    31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014

  4. Frequency (number) of reported ESS505 (device) wearing-related AEs

    Time frame: 3 months

    31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014

  5. Severity of reported ESS505 wearing-related AEs

    Time frame: 3 months

    31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 24, 2013
Registry last updated
Mar 21, 2017

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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