Study 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

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

Trial summary

Enrollment Goal

Trial Dates

January 2013 - September 2014

Phase

N/A

Could I Receive a placebo

Products

ESS505 (BAY1454033)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
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.
Time Frame:
3 months
Safety Issue:
No

Secondary Outcome

Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception
Time Frame:
12 months
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.
Time Frame:
3 months
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
Time Frame:
3 months
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
Time Frame:
3 months
Safety Issue:
Yes
Severity of reported ESS505 wearing-related AEs
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Time Frame:
3 months
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

Additional Information

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