Prospective Multi-Center Trial for FemBloc Permanent Birth Control (FINALE)

Femasys

Status: Enrolling

Conditions: Contraception

Treatments: Device: FemBloc

Study type: Interventional

Funder types: Industry

Identifiers

NCT05977751

CP-100-009

Details and patient eligibility

About

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

Enrollment: 573 estimated patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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573 participants in 1 patient group

FemBloc

Experimental group

Description:

Investigational device and procedure

Treatment:

Device: FemBloc