Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the study was to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy. Femasys continued follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
49
The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Blended Polymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).
The Stamford Hospital
Stamford, Connecticut, United States
QPS Miami Research Associates
Miami, Florida, United States
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Number of Subjects Who Experience an Adverse Event Divided by the Number of Subjects Exposed to the FemBloc System (Blended Polymer Treatment and Confirmation Test)
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc System. Evaluated up to 3 months after the FemBloc Treatment and Confirmation Test (device and/or procedure related AEs) and then through 5 years.
Time frame: 3 months (pilot study safety endpoint and then through 5 years)
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Chattanooga Medical Research
Chattanooga, Tennessee, United States