RECRUITING

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Description

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Conditions

Contraception
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Related Conditions:

Contraception

Study Overview

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Study Details

Study overview

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Condition
Contraception
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Sacramento

University of California Davis, Sacramento, California, United States, 95817

Columbus

Midtown OB GYN North, Columbus, Georgia, United States, 31909

Brooklyn

Maimonides Medical Center, Brooklyn, New York, United States, 11219-2919

Cincinnati

Seven Hills Women's Health Centers, Cincinnati, Ohio, United States, 45242

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

21 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Femasys Inc.,

Study Sponsor, STUDY_DIRECTOR, Medical Affairs and Clinical Development

Study Record Dates

2031-06