RecruitingNot ApplicableNCT05977751
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
Sponsor
Femasys Inc.
Enrollment
573 participants
Start Date
Oct 31, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Eligibility
Sex: FEMALEMin Age: 21 YearsMax Age: 50 Years
Inclusion Criteria3
- 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.
Exclusion Criteria6
- 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.
- Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
- Abnormal uterine bleeding requiring evaluation or treatment.
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Interventions
DEVICEFemBloc
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT05977751
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