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Observational Study on Contraception With Essure in France (SUCCES II)

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ClinicalTrials.gov Identifier: NCT02510443
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
Hôpital André Mignot Centre Hospitalier de Versailles
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Contraception Device: ESS305 (Essure, BAY1454032)

Detailed Description:
The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice

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Study Type : Observational
Actual Enrollment : 2644 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey on Use and Characteristics of Definitive Contraception With ESsure®
Actual Study Start Date : June 23, 2008
Actual Primary Completion Date : September 29, 2016
Actual Study Completion Date : November 25, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
BAY1454032
All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure
Device: ESS305 (Essure, BAY1454032)
Bilateral insert placement




Primary Outcome Measures :
  1. Number of patients being satisfied with successful Essure procedure having no complications at 5 years [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of patients with moderate or important pain when placement is performed [ Time Frame: At initial visit ]
    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.

  2. Number of unsatisfied patients [ Time Frame: Up to 5 years ]
  3. Number of satisfied patients at 3, 12 and 24 months [ Time Frame: At 3 ,12 and 24 months ]
    Patients satisfaction assessed by Likert scale.

  4. Number of examinations by patients [ Time Frame: At 3 months ]
  5. Number of good insert position by implant and patients with success in final result of the procedure [ Time Frame: At 3 months ]
  6. Causes of unsatisfied patients [ Time Frame: Up to 5 years ]
    Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection

  7. Type of examinations by patients [ Time Frame: At 3 months ]
    Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)

  8. Number of patients with regrets [ Time Frame: At 12 months, 24 months and 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510443


Locations
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France
Le Chesnay, France, 78150
Sponsors and Collaborators
Bayer
Hôpital André Mignot Centre Hospitalier de Versailles
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02510443     History of Changes
Other Study ID Numbers: 18097
ES0810FR ( Other Identifier: Company Internal )
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Bayer:
Permanent contraception method
Contraceptive device