check_circleStudy Completed
Contraception
Bayer Identifier:
16973
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
Trial purpose
The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.
Key Participants Requirements
Sex
FemaleAge
21 - 44 YearsTrial summary
Enrollment Goal
660Trial Dates
September 2013 - September 2024Phase
N/ACould I Receive a placebo
NoProducts
ESS505 (BAY1454033)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bronx, 10467, United States | |
Completed | Spokane, 99204, United States | |
Completed | Newburgh, 47630, United States | |
Withdrawn | Independence, 94925, United States | |
Completed | Houston, 77074, United States | |
Completed | Fort Wayne, 46825, United States | |
Completed | New York, 10032, United States | |
Completed | Asheville, 28801, United States | |
Completed | Córdoba, 14004, Spain | |
Completed | Hamilton, L8L 2X2, Canada | |
Completed | ZWOLLE, 8025 AB, Netherlands | |
Completed | L'Hospitalet de llobregat, 08906, Spain | |
Completed | Dallas, 75208, United States | |
Completed | Columbia, 60004, United States | |
Completed | Regina, S4S 6X3, Canada | |
Completed | Cincinnati, 45242, United States | |
Completed | Aurora, 80045, United States | |
Completed | Norfolk, 23507, United States | |
Completed | Rochester, 55905, United States | |
Completed | Saginaw, 48604, United States | |
Completed | Wellington, 33414, United States | |
Completed | Irving, 75062, United States | |
Completed | Denver, 80231, United States |
Primary Outcome
- Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraceptionEvaluated after 6000 women-months of reliance have been accumulateddate_rangeTime Frame:1 yearenhanced_encryptionNoSafety Issue:
- Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attemptedEvaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)date_rangeTime Frame:3 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraceptiondate_rangeTime Frame:10 yearsenhanced_encryptionNoSafety Issue:
- Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tubedate_rangeTime Frame:On day of placement procedureenhanced_encryptionYesSafety Issue:
- Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assesseddate_rangeTime Frame:Up to 10 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
PreventionAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1