Trial Condition(s):
Contraception
Observational study on contraception with Essure in France (SUCCES II)
Bayer Identifier:
18097
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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.
Trial Summary
Enrollment Goal
2644
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site LE CHESNAY, France, 78150 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Number of patients being satisfied with successful Essure procedure having no complications at 5 yearsPatient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point.Timeframe: At 5 years
Secondary Outcome
- Number of patients with moderate or important pain when placement is performedVisual 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.Timeframe: At initial visit
- Number of unsatisfied patientsTimeframe: Up to 5 years
- Number of satisfied patients at 3, 12 and 24 monthsPatients satisfaction assessed by Likert scale.Timeframe: At 3 ,12 and 24 months
- Number of examinations by patientsTimeframe: At 3 months
- Number of good insert position by implant and patients with success in final result of the procedureTimeframe: At 3 months
- Causes of unsatisfied patientsPossible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infectionTimeframe: Up to 5 years
- Type of examinations by patientsUltrasound transvaginale, radiography, or hysterosalpingography (HSG)Timeframe: At 3 months
- Number of patients with regretsTimeframe: At 12 months, 24 months and 5 years
Additional Information
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