check_circleStudy Completed

Contraception

Bayer Identifier:

18097

ClinicalTrials.gov Identifier:

NCT02510443

EudraCT Number:

Not Available

EU CT Number:

Not Available
Observational study on contraception with Essure in France

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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.

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

Trial summary

Enrollment Goal
2644
Trial Dates
June 2008 - November 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
LE CHESNAY, 78150, France

Primary Outcome

  • 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.
    date_rangeTime Frame:
    At 5 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of patients with moderate or important pain when placement is performed
    Visual Analogue Scale (VAS) use to report the pain from 0 (no pain) to 10 (maximal pain). Moderate pain will range from 4 to 6 and important pain will range from 7 to 10 on the VAS.
    date_rangeTime Frame:
    At initial visit
    enhanced_encryption
    Safety Issue:
    No
  • Number of unsatisfied patients
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of satisfied patients at 3, 12 and 24 months
    Patients satisfaction assessed by Likert scale.
    date_rangeTime Frame:
    At 3 ,12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of examinations by patients
    date_rangeTime Frame:
    At 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of good insert position by implant and patients with success in final result of the procedure
    date_rangeTime Frame:
    At 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Causes of unsatisfied patients
    Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    No
  • Type of examinations by patients
    Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)
    date_rangeTime Frame:
    At 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with regrets
    date_rangeTime Frame:
    At 12 months, 24 months and 5 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Survey on Use and Characteristics of definitive Contraception with ESsure®
Trial Type
Observational
Intervention Type
Device
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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