RECRUITING

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

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Conditions

ContraceptionPermanent Birth ControlPermanent ContraceptionPermanent Sterilization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-10-31
Study Completion:2031-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05977751

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.

Ages Eligible for Study:21 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, 21 - 50 years of age desiring permanent birth control.
  2. * Sexually active with male partner.
  3. * Regular menstrual cycle for last 3 months or on hormonal contraceptives.
  1. * Uncertainty about the desire to end fertility.
  2. * Known or suspected pregnancy.
  3. * Prior tubal surgery, including sterilization attempt.
  4. * Presence, suspicion, or previous history of gynecologic malignancy.
  5. * Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
  6. * Abnormal uterine bleeding requiring evaluation or treatment.

Contacts and Locations

Study Contact

Study Director
CONTACT
770-500-3910 Ext. 146
StudySupport@Femasys.com

Principal Investigator

Study Sponsor
STUDY_DIRECTOR
Medical Affairs and Clinical Development

Study Locations (Sites)

Stanford University
Palo Alto, California, 94304
United States
University of California Davis
Sacramento, California, 95817
United States
Midtown OB GYN North
Columbus, Georgia, 31909
United States
Maimonides Medical Center
Brooklyn, New York, 11219-2919
United States
Seven Hills Women's Health Centers
Cincinnati, Ohio, 45242
United States
University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: Femasys Inc.

  • Study Sponsor, STUDY_DIRECTOR, Medical Affairs and Clinical Development

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-31
Study Completion Date2031-06

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

  • Permanent Birth Control
  • Permanent Contraception
  • Permanent Sterilization

Additional Relevant MeSH Terms

  • Contraception