Prospective Multi-Center Trial for FemBloc Permanent Birth Control
NCT ID: NCT05977751
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
573 participants
INTERVENTIONAL
2023-10-31
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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FemBloc
Investigational device and procedure
FemBloc
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
Interventions
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FemBloc
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
Eligibility Criteria
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Inclusion Criteria
* Sexually active with male partner.
* Regular menstrual cycle for last 3 months or on hormonal contraceptives.
Exclusion Criteria
* 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.
21 Years
50 Years
FEMALE
Yes
Sponsors
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Femasys Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Sponsor
Role: STUDY_DIRECTOR
Medical Affairs and Clinical Development
Locations
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Stanford University
Palo Alto, California, United States
University of California Davis
Sacramento, California, United States
Midtown OB GYN North
Columbus, Georgia, United States
Maimonides Medical Center
Brooklyn, New York, United States
Seven Hills Women's Health Centers
Cincinnati, Ohio, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Research Coordinator
Role: primary
Research Coordinator
Role: primary
Research Coordinator
Role: primary
Research Coordinator
Role: primary
Research Coordinator
Role: primary
Research Coordinator
Role: primary
Related Links
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FemBloc Clinical Study Website
Other Identifiers
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CP-100-009
Identifier Type: -
Identifier Source: org_study_id
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