NCT01948882

Brief Summary

The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
4 countries

22 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

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

September 30, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2015

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2024

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

September 19, 2013

Last Update Submit

October 16, 2024

Conditions

Contraception

Keywords

Birth control

Outcome Measures

Primary Outcomes (2)

  • Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception

    Evaluated after 6000 women-months of reliance have been accumulated

    1 year

  • Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted

    Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)

    3 months

Secondary Outcomes (3)

  • Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception

    10 years

  • Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube

    On day of placement procedure

  • Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed

    Up to 10 years

Study Arms (1)

ESS505

EXPERIMENTAL

All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.

Device: ESS505 (BAY1454033)

Interventions

ESS505 (BAY1454033)DEVICE
ESS505

Eligibility Criteria

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

You may qualify if:

  • Female, 21 to 44 years of age, inclusive
  • Body weight within range of 90-300 lbs (40 - 136 kg)
  • Sexually active (minimum of 4 coital acts per cycle)
  • Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
  • Medical history indicates bilateral viable and patent fallopian tubes
  • Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods

You may not qualify if:

  • Post-menopausal woman
  • Suspected or confirmed pregnancy
  • Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
  • Past fallopian tube sterilization procedure and/or total or partial salpingectomies
  • Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
  • Currently taking corticosteroids
  • Known allergy to all contrast media available for use in hysterosalpingogram
  • Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
  • Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Denver, Colorado, 80231, United States

Location

Unknown Facility

Wellington, Florida, 33414, United States

Location

Unknown Facility

Fort Wayne, Indiana, 46825, United States

Location

Unknown Facility

Newburgh, Indiana, 47630, United States

Location

Unknown Facility

Saginaw, Michigan, 48604, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

The Bronx, New York, 10467, United States

Location

Unknown Facility

Asheville, North Carolina, 28801, United States

Location

Unknown Facility

Cincinnati, Ohio, 45242, United States

Location

Unknown Facility

Columbia, Ohio, 60004, United States

Location

Unknown Facility

Dallas, Texas, 75208, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Unknown Facility

Irving, Texas, 75062, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Unknown Facility

Spokane, Washington, 99204, United States

Location

Unknown Facility

Hamilton, Ontario, L8L 2X2, Canada

Location

Unknown Facility

Regina, Saskatchewan, S4S 6X3, Canada

Location

Unknown Facility

Zwolle, 8025 AB, Netherlands

Location

Unknown Facility

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Unknown Facility

Córdoba, 14004, Spain

Location

Related Links

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

September 19, 2013

First Posted

September 24, 2013

Study Start

September 30, 2013

Primary Completion

September 16, 2015

Study Completion

September 12, 2024

Last Updated

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

CA(2)NL(1)US(17)ES(2)