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Active, Not Recruiting

NCT Number: NCT04273594

FemBloc® Permanent Contraception - Confirmation Feasibility Trial

The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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

Loading trial locations.

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
  • 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
  • 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)
  • Allergy to shellfish, betadine or iodinated contrast

Treatment and study plan

FemBloc

Device

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

Primary outcomes

  1. Reliance Rate

    Time frame: within 1 year

    Number of subjects told to rely divided by number of qualified subjects

  2. Concordance

    Time frame: within 1 year

    Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation

Sponsors and collaborators

Lead sponsor

Femasys Inc.

Industry

Registry information

Official study title

BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)

Acronym: BLOC

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Feb 18, 2020
Registry last updated
Jan 28, 2025

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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