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.
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Study Type
OBSERVATIONAL
Enrollment
211
Essure Permanent Birth Control
Nova Sure Endometrial Ablation
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Ocala, Florida, United States
Unnamed facility
Decatur, Illinois, United States
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
Time frame: 1 year after NovaSure Endometrial Ablation procedure
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
Time frame: 3 years after NovaSure Endometrial Ablation procedure
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
An 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.
Time frame: After 3-year follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fort Wayne, Indiana, United States
Unnamed facility
Newburgh, Indiana, United States
Unnamed facility
Easton, Maryland, United States
Unnamed facility
Grand Blanc, Michigan, United States
Unnamed facility
Maplewood, Minnesota, United States
Unnamed facility
Las Vegas, Nevada, United States
Unnamed facility
Neptune City, New Jersey, United States
...and 7 more locations