check_circleStudy Completed

Contraception

Bayer Identifier:

17035

ClinicalTrials.gov Identifier:

NCT01664052

EudraCT Number:

Not Available

EU CT Number:

Not Available
ESS505 Pre-hysterectomy Protocol

Trial purpose

This study has been designed to evaluate an investigational model of the Essure System for Permanent Birth Control. The investigational device is designed to offer all the advantages of the currently approved device. In addition, the investigational device offers immediate, permanent contraception without a three-month waiting period or 90-day confirmation test. This study has been designed to evaluate the effectiveness of the investigational device in causing tubal occlusion from insert placement through three months of wearing.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH), Total Vaginal Hysterectomy (TVH), Total Laparoscopic Hysterectomy (TLH) with Bilateral Total Salpingectomy or Bilateral Salpingo-oophorectomy (BSO), or Laparoscopic Supracervical Hysterectomy (LSH)
    - Subjects who are 18 years of age and older
    - Subjects who are able and willing to provide written informed consent
    - Subjects who agree to use a contraceptive method following Essure placement until the hysterectomy procedure
  • - Subjects with bilateral proximal tubal occlusion
    - Subjects who have undergone fallopian tube sterilization
    - Subjects with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia
    - Subjects who are post-menopausal
    - Subjects with pelvic inflammatory disease (PID)
    - Subjects with gynecologic malignancy
    - Pregnancy or suspected pregnancy
    - Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement
    - Known allergy to contrast media
    - Any general health condition that may represent, in the opinion of the Investigator, an increased potential risk associated with participation

Trial summary

Enrollment Goal
66
Trial Dates
July 2012 - March 2013
Phase
N/A
Could I Receive a placebo
No
Products
ESS505 (BAY1454033)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Regina, S4P 0W5, Canada
Completed
Chihuahua, 31350, Mexico

Primary Outcome

  • Number of occluded fallopian tubes 60 minutes after placement of the insert as measured by an HSG evaluation
    Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.
    date_rangeTime Frame:
    60 minutes after insert placement
    enhanced_encryption
    Safety Issue:
    No
  • Number of occluded fallopian tubes 30 days following placement as measured by an HSG evaluation
    Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
    date_rangeTime Frame:
    30 days after insert placement
    enhanced_encryption
    Safety Issue:
    No
  • Number of occluded fallopian tubes 60 days following placement as measured by an HSG evaluation
    Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
    date_rangeTime Frame:
    60 days after insert placement
    enhanced_encryption
    Safety Issue:
    No
  • Number of occluded fallopian tubes 90 days following placement as measured by an HSG evaluation
    Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
    date_rangeTime Frame:
    90 days after insert placement
    enhanced_encryption
    Safety Issue:
    No

Trial design

ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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