Prospective Multi-Center Trial for FemBloc Permanent Birt... | NCT05977751

Studies
Prospective Multi-Center Trial for FemBloc Permanent Birth Control

NCT05977751

Sponsor

Femasys Inc.

Status

Recruiting

Last Update Posted

Mar 3, 2026Actual

Enrollment

573Estimated

Phase

Not Applicable

Conditions

Contraception

Interventions

FemBloc

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2023Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Jun 2031Estimated

First Submitted Date

Jul 27, 2023

First Submission Date that Met QC Criteria

Aug 3, 2023

First Posted Date

Aug 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2026

Last Update Posted Date

Mar 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Detailed Description

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

573Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FemBloc	Experimental	Investigational device and procedure	Device: FemBloc

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FemBloc	Device	Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.	FemBloc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy Rate	Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.	one (1) year

Secondary Outcomes

Measure	Description	Time Frame
Reliance Rate	Number of subjects who were told to rely on FemBloc.	ninety (90) days post treatment
Long term Pregnancy Rate	Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, 21 - 50 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.
Presence, suspicion, or previous history of gynecologic malignancy.
Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
Abnormal uterine bleeding requiring evaluation or treatment.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Director	Contact	770-500-3910 Ext. 146		StudySupport@Femasys.com

Overall Officials

Name	Affiliation	Role
Study Sponsor	Medical Affairs and Clinical Development	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Horizons Clinical Trials	Recruiting	Chandler	Arizona	85224	United States