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
|Condition or disease||Intervention/treatment|
|Contraception||Device: ESS305 (Essure, BAY1454032)|
|Study Type :||Observational|
|Actual Enrollment :||2644 participants|
|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|
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
- 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.
- 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.
- Number of unsatisfied patients [ Time Frame: Up to 5 years ]
- Number of satisfied patients at 3, 12 and 24 months [ Time Frame: At 3 ,12 and 24 months ]Patients satisfaction assessed by Likert scale.
- Number of examinations by patients [ Time Frame: At 3 months ]
- Number of good insert position by implant and patients with success in final result of the procedure [ Time Frame: At 3 months ]
- 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
- Type of examinations by patients [ Time Frame: At 3 months ]Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)
- Number of patients with regrets [ Time Frame: At 12 months, 24 months and 5 years ]
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
|Le Chesnay, France, 78150|
|Study Director:||Bayer Study Director||Bayer|