FemBloc® Permanent Contraception - Early Pivotal Trial (BLOC)

Femasys

Status: Active, not recruiting

Conditions: Contraception

Treatments: Device: FemBloc; Procedure: Laparoscopic bilateral tubal sterilization

Study type: Interventional

Funder types: Industry

Identifiers

NCT03433911

CP-100-007

Details and patient eligibility

About

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.

Enrollment: 240 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

• 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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

FemBloc

Experimental group

Description:

Investigational device and procedure

Treatment:

Device: FemBloc

Control

Active Comparator group

Description:

Laparoscopic bilateral tubal sterilization

Treatment:

Procedure: Laparoscopic bilateral tubal sterilization