NCT01861886

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2014

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

February 20, 2013

Last Update Submit

March 20, 2017

Conditions

Contraception

Keywords

Birth controlPermanent Contraception

Outcome Measures

Primary Outcomes (1)

  • Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.

    3 months

Secondary Outcomes (5)

  • Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception

    12 months

  • Frequency (number) of reported ESS505 placement procedure-related AEs

    3 months

  • Severity of reported ESS505 placement procedure-related AEs

    3 months

  • Frequency (number) of reported ESS505 (device) wearing-related AEs

    3 months

  • Severity of reported ESS505 wearing-related AEs

    3 months

Study Arms (1)

ESS505

EXPERIMENTAL

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)

Interventions

ESS505 (BAY1454033)DEVICE

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.

ESS505

Eligibility Criteria

Age21 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Hoofddorp, 2134 TM, Netherlands

Location

Unknown Facility

Nieuwegein, 3435 CM, Netherlands

Location

Unknown Facility

Tiel, 4002 WP, Netherlands

Location

Unknown Facility

Zwolle, 8025 AB, Netherlands

Location

Unknown Facility

Córdoba, Córdoba, 14004, Spain

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2013

First Posted

May 24, 2013

Study Start

January 31, 2013

Primary Completion

December 19, 2013

Study Completion

September 30, 2014

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

NL(4)ES(1)