The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
45
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
New Horizons Clinical Trials
Chandler, Arizona, United States
Precision Trials AZ, LLC
Phoenix, Arizona, United States
Midtown OB GYN North
Columbus, Georgia, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Reliance Rate
Number of subjects told to rely divided by number of qualified subjects
Time frame: within 1 year
Concordance
Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation
Time frame: within 1 year
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Saginaw Valley Medical Research Group
Saginaw, Michigan, United States
University Hospitals - Cleveland Medical Center
Beachwood, Ohio, United States