FemBloc® Permanent Contraception - Confirmation Feasibility Trial (BLOC)

Femasys

Status: Active, not recruiting

Conditions: Contraception

Treatments: Device: FemBloc

Study type: Interventional

Funder types: Industry

Identifiers

NCT04273594

CP-100-008

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

FemBloc

Experimental group

Description:

Investigational device and procedure

Treatment:

Device: FemBloc