Prospective Multi-Center Trial for FemBloc Permanent Birth Control

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05977751

Acronym

FINALE

Enrollment

573

Registered

2023-08-04

Start date

2023-10-31

Completion date

2031-06-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Permanent Birth Control, Permanent Contraception, Permanent Sterilization

Brief summary

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

Detailed description

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

Interventions

DEVICEFemBloc

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pregnancy Rate	one (1) year	Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.

Secondary

Measure	Time frame	Description
Reliance Rate	ninety (90) days post treatment	Number of subjects who were told to rely on FemBloc.
Long term Pregnancy Rate	Five (5) years	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.

Countries

United States

Contacts

CONTACTStudy Director

StudySupport@Femasys.com770-500-3910 Ext. 146

STUDY_DIRECTORStudy Sponsor

Medical Affairs and Clinical Development

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026