Trial Condition(s):

Contraception

Observational study on contraception with Essure in France (SUCCES II)

Bayer Identifier:

18097

ClinicalTrials.gov Identifier:

NCT02510443

EudraCT 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
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Phase
4
Could I receive a placebo?
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

LE CHESNAY, France, 78150

Status
Completed
 

Trial Design