check_circleStudy Completed
Contraception, Menorrhagia
Bayer Identifier:
16975
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
Trial purpose
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
Key Participants Requirements
Sex
FemaleAge
21 - 50 YearsTrial summary
Enrollment Goal
211Trial Dates
November 2012 - June 2021Phase
N/ACould I Receive a placebo
NoProducts
Essure (ESS305, BAY1454032)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pottstown, 19464, United States | |
Completed | Nashville, 37232, United States | |
Withdrawn | Columbus, 43214, United States | |
Completed | Newburgh, 47630, United States | |
Withdrawn | Phoenix, 85015, United States | |
Completed | Easton, 21601, United States | |
Withdrawn | Winston-Salem, 27103, United States | |
Withdrawn | Denver, 80220, United States | |
Completed | Decatur, 62526, United States | |
Completed | Fort Wayne, 46825, United States | |
Completed | Spokane, 99204, United States | |
Completed | Grand Blanc, 48439, United States | |
Completed | Las Vegas, 89102, United States | |
Withdrawn | Nashville, 37232, United States | |
Withdrawn | Columbus, 43231, United States | |
Completed | Aurora, 80045, United States | |
Withdrawn | Dayton, 45409, United States | |
Completed | Ocala, 34471, United States | |
Completed | Winston-Salem, 27103, United States | |
Completed | Mason, 45040, United States | |
Completed | Maplewood, 55109, United States | |
Completed | Newburgh, 47630, United States | |
Completed | Englewood, 45322, United States | |
Completed | Norfolk, 23507, United States | |
Completed | Neptune, 07753, United States |
Primary Outcome
- Number of pregnancies at 1-year time point (1-year pregnancy rate)date_rangeTime Frame:1 year after NovaSure Endometrial Ablation procedure
- Number of pregnancies at 3-year time point (3-year pregnancy rate)date_rangeTime Frame:3 years after NovaSure Endometrial Ablation procedure
Secondary Outcome
- Number of adverse events (AEs) when NovaSure endometrial ablation was performed in the presence of Essure insertsAn adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A serious adverse event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another serious or important medical event (IME) as judged by the investigator, or requires intervention to prevent permanent impairment of a body function or damage to a body structure.date_rangeTime Frame:After 3-year follow-up
Trial design
Trial Type
ObservationalIntervention Type
DeviceTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A