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

F

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

573 participants in 1 patient group

FemBloc
Experimental group
Description:
Investigational device and procedure
Treatment:
Device: FemBloc

Trial contacts and locations

0

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Central trial contact

Study Director

Data sourced from clinicaltrials.gov

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