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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861886
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Device: ESS505 (BAY1454033) Not Applicable

Detailed Description:
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : January 31, 2013
Actual Primary Completion Date : December 19, 2013
Actual Study Completion Date : September 30, 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861886


Locations
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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
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01861886    
Other Study ID Numbers: 16972
ESS505-003 ( Other Identifier: Company Internal )
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Keywords provided by Bayer:
Birth control
Permanent Contraception