The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

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

To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: ESS505 (BAY1454033)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Hoofddorp, Netherlands, 2134 TM
  • Nieuwegein, Netherlands, 3435 CM
  • Tiel, Netherlands, 4002 WP
  • Zwolle, Netherlands, 8025 AB
• Spain
  • Córdoba, Spain, 14004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESS505; 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); 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Date of enrollment, 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014.	3 months
Severity of reported ESS505 placement procedure-related AEs	31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014	3 months
Frequency (number) of reported ESS505 (device) wearing-related AEs	31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014	3 months
Severity of reported ESS505 wearing-related AEs	31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014	3 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2013
• Primary Completion (Actual): December 19, 2013
• Study Completion (Actual): September 30, 2014

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Birth control; Permanent Contraception
• Other Study ID Numbers: 16972; ESS505-003 (Other Identifier: Company Internal)