Trials / Active Not Recruiting
Active Not RecruitingNCT04273594
FemBloc® Permanent Contraception - Confirmation Feasibility Trial
BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Femasys Inc. · Industry
- Sex
- Female
- Age
- 21 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FemBloc | Treatment with FemBloc for women who desire permanent birth control (female sterilization) |
Timeline
- Start date
- 2020-02-27
- Primary completion
- 2022-09-30
- Completion
- 2027-04-01
- First posted
- 2020-02-18
- Last updated
- 2025-01-28
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04273594. Inclusion in this directory is not an endorsement.