NCT02510443

Brief Summary

Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,644

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

June 23, 2008

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2016

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

8.3 years

First QC Date

June 15, 2015

Last Update Submit

September 12, 2017

Conditions

Contraception

Keywords

Permanent contraception methodContraceptive device

Outcome Measures

Primary Outcomes (1)

  • Number of patients being satisfied with successful Essure procedure having no complications at 5 years

    Patient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point.

    At 5 years

Secondary Outcomes (8)

  • Number of patients with moderate or important pain when placement is performed

    At initial visit

  • Number of unsatisfied patients

    Up to 5 years

  • Number of satisfied patients at 3, 12 and 24 months

    At 3 ,12 and 24 months

  • Number of examinations by patients

    At 3 months

  • Number of good insert position by implant and patients with success in final result of the procedure

    At 3 months

  • +3 more secondary outcomes

Study Arms (1)

BAY1454032

All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure

Device: ESS305 (Essure, BAY1454032)

Interventions

ESS305 (Essure, BAY1454032)DEVICE

Bilateral insert placement

BAY1454032

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients concerned are adult women wishing to undergo tubal sterilization for contraceptive purposes, in accordance with legal provisions, who had given their consent for collection of the data.

You may qualify if:

  • Woman ≥ 18 years old,
  • Scheduled for Essure procedure
  • Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.

You may not qualify if:

  • Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Le Chesnay, 78150, France

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

July 29, 2015

Study Start

June 23, 2008

Primary Completion

September 29, 2016

Study Completion

November 25, 2016

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

FR(1)