Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT04273594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FemBloc® Permanent Contraception - Confirmation Feasibility Trial
Sponsor:
Femasys Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLOC
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: