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NCT Number: NCT05977751

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

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

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Key information

Conditions

Contraception

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New Horizons Clinical Trials, Chandler, Arizona, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FemBloc

Device

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

Primary outcomes

  1. Pregnancy Rate

    Time frame: one (1) year

    Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.

Secondary outcomes

  1. Reliance Rate

    Time frame: ninety (90) days post treatment

    Number of subjects who were told to rely on FemBloc.

  2. Long term Pregnancy Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

770-500-3910 Ext. 146

Sponsors and collaborators

Lead sponsor

Femasys Inc.

Industry

Registry information

Official study title

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

Acronym: FINALE

Important dates

Study start
2023
Primary completion
2029
Study completion
2031
First posted
Aug 4, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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