Prospective Multi-Center Trial for FemBloc Permanent Birth Control
ConditionContraception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-50
SponsorFemasys Inc.
About this trial
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female, 21 - 50 years of age desiring permanent birth control.
Sexually active with male partner.
Regular menstrual cycle for last 3 months or on hormonal contraceptives.
Disqualifiers
Uncertainty about the desire to end fertility.
Known or suspected pregnancy.
Prior tubal surgery, including sterilization attempt.
Presence, suspicion, or previous history of gynecologic malignancy.
Trial design
Design model
Single group
Treatments tested in this trial
FemBloc
DeviceTreatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
Treatment groups
573 Participants
are divided into 1 treatment groupGroup A: FemBlocExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pregnancy Rate
Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.
Time frame
one (1) yearSecondary outcomes
1
Reliance Rate
Number of subjects who were told to rely on FemBloc.
Time frame
ninety (90) days post treatment2
Long term Pregnancy Rate
Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years.
Time frame
Five (5) yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov