FemBloc® Permanent Contraception - Confirmation Feasibility Trial

Contraception Clinical Trial

— BLOC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04273594
• Other study ID #: CP-100-008
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: April 2027

Study information

• Verified date: August 2023
• Source: Femasys Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: April 2027
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals - Cleveland Medical Center	Beachwood	Ohio
United States	New Horizons Clinical Trials	Chandler	Arizona
United States	Midtown OB GYN North	Columbus	Georgia
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	Precision Trials AZ, LLC	Phoenix	Arizona
United States	Saginaw Valley Medical Research Group	Saginaw	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Femasys Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliance Rate	Number of subjects told to rely divided by number of qualified subjects	within 1 year
Primary	Concordance	Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation	within 1 year