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Clinical Trials/NCT01861886
NCT01861886CompletedNot Applicable

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

Bayer5 sites in 2 countries73 target enrollmentStarted: January 31, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
73
Locations
5
Primary Endpoint
Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
21 Years to 44 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: ESS505 (BAY1454033) (Device)

Outcomes

Primary Outcomes

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

Time Frame: 3 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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