Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Contraception Clinical Trial

— FINALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977751
• Other study ID #: CP-100-009
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: June 2031

Study information

• Verified date: January 2024
• Source: Femasys Inc.
• Contact: Study Director
• Phone: 770-500-3910 Ext. 146
• Email: StudySupport[@]Femasys.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 573
• Est. completion date: June 2031
• Est. primary completion date: December 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• FemBloc
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York
United States	Seven Hills Women's Health Centers	Cincinnati	Ohio
United States	Midtown OB GYN North	Columbus	Georgia
United States	Stanford University	Palo Alto	California
United States	University of California Davis	Sacramento	California
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Femasys Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.	one (1) year
Secondary	Reliance Rate	Number of subjects who were told to rely on FemBloc.	ninety (90) days post treatment
Secondary	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.	Five (5) years

External Links

•   FemBloc Clinical Study Website