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Completed

NCT Number: NCT03433911

FemBloc® Permanent Contraception - Early Pivotal Trial

Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.

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Key information

Conditions

Contraception

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New Horizons Clinical Trials, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female, 21 - 45 years of age desiring permanent birth control
  • Sexually active with male partner
  • For FemBloc Arm:
  • Regular menstrual cycle for last 3 months or on hormonal contraceptives
  • For Control Arm:
  • Undergoing planned laparoscopic bilateral tubal sterilization

Exclusion criteria

  • Uncertainty about the desire to end fertility
  • Known or suspected pregnancy
  • Prior tubal surgery, including sterilization attempt
  • Prior endometrial ablation
  • Presence, suspicion, or previous history of gynecologic malignancy
  • Abnormal uterine bleeding requiring evaluation or treatment
  • Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)

Treatment and study plan

FemBloc

Device

Treatment with FemBloc for women who desire permanent birth control (female sterilization)

Laparoscopic bilateral tubal sterilization

Procedure

Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

Primary outcomes

  1. Incidence of short-term and long-term adverse events in each arm

    Time frame: 1-5 years

    Safety: Incidence of short-term and long-term adverse events in each arm

Sponsors and collaborators

Lead sponsor

Femasys Inc.

Industry

Registry information

Official study title

BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Acronym: BLOC

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Feb 15, 2018
Registry last updated
Feb 27, 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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