check_circleStudy Completed

Contraception

Bayer Identifier:

16972

ClinicalTrials.gov Identifier:

NCT01861886

EudraCT Number:

Not Available

EU CT Number:

Not Available
The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

Trial 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.

Key Participants Requirements

Sex

Female

Age

21 - 44 Years
  • - 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)
  • - 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

Trial summary

Enrollment Goal
73
Trial Dates
January 2013 - September 2014
Phase
N/A
Could I Receive a placebo
No
Products
ESS505 (BAY1454033)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Córdoba, 14004, Spain
Completed
HOOFDDORP, 2134 TM, Netherlands
Completed
NIEUWEGEIN, 3435 CM, Netherlands
Completed
ZWOLLE, 8025 AB, Netherlands
Completed
Tiel, 4002 WP, Netherlands

Primary Outcome

  • Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
    date_rangeTime Frame:
    3 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Frequency (number) of reported ESS505 placement procedure-related AEs
    Date of enrollment, 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014.
    date_rangeTime Frame:
    3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Severity of reported ESS505 placement procedure-related AEs
    31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
    date_rangeTime Frame:
    3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Frequency (number) of reported ESS505 (device) wearing-related AEs
    31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
    date_rangeTime Frame:
    3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Severity of reported ESS505 wearing-related AEs
    31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
    date_rangeTime Frame:
    3 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Prevention
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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