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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01861886
First received: February 20, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Contraception
Device: ESS505 (BAY1454033)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception. [ Time Frame: 3 months post placement of ESS505 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception [ Time Frame: 12 months post ESS505 placement ] [ Designated as safety issue: No ]
  • Frequency of reported ESS505 placement procedure-related AEs [ Time Frame: Day of placement of ESS505 ] [ Designated as safety issue: Yes ]
  • Severity of reported ESS505 placement procedure-related AEs [ Time Frame: Day of placement of ESS505 ] [ Designated as safety issue: Yes ]
  • Frequency of reported ESS505 wearing-related AEs [ Time Frame: 12 months post ESS505 placement ] [ Designated as safety issue: Yes ]
  • Severity of reported ESS505 wearing-related AEs [ Time Frame: 12 months post ESS505 placement ] [ Designated as safety issue: Yes ]

Enrollment: 73
Study Start Date: January 2013
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESS505
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.
Device: ESS505 (BAY1454033)
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861886

Locations
Netherlands
Hoofddorp, Netherlands, 2134 TM
Nieuwegein, Netherlands, 3435 CM
Tiel, Netherlands, 4002 WP
Zwolle, Netherlands, 8025 AB
Spain
Córdoba, Spain, 14004
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01861886     History of Changes
Other Study ID Numbers: 16972, ESS505-003
Study First Received: February 20, 2013
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Bayer:
Birth control
Permanent Contraception

ClinicalTrials.gov processed this record on August 01, 2014