Study 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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Dates

July 2012 - March 2013

Phase

N/A

Could I Receive a placebo

Products

ESS505 (BAY1454033)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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.
Time Frame:
60 minutes after insert placement
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.
Time Frame:
30 days after insert placement
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.
Time Frame:
60 days after insert placement
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.
Time Frame:
90 days after insert placement
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

Additional Information

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