FemBloc® Permanent Contraception - Early Pivotal Trial | NCT03433911

Studies
FemBloc® Permanent Contraception - Early Pivotal Trial

NCT03433911

Sponsor

Femasys Inc.

Status

Completed

Last Update Posted

Feb 27, 2026Actual

Enrollment

240Actual

Phase

Not Applicable

Conditions

Contraception

Interventions

FemBloc
Laparoscopic bilateral tubal sterilization

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2018Actual

Primary Completion Date

Jan 31, 2020Actual

Completion Date

Feb 10, 2025Actual

First Submitted Date

Feb 1, 2018

First Submission Date that Met QC Criteria

Feb 8, 2018

First Posted Date

Feb 15, 2018Actual

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

Feb 24, 2026

Last Update Posted Date

Feb 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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, 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.

Detailed Description

Not provided

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

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FemBloc	Experimental	Investigational device and procedure	Device: FemBloc
Control	Active Comparator	Laparoscopic bilateral tubal sterilization	Procedure: Laparoscopic bilateral tubal sterilization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FemBloc	Device	Treatment with FemBloc for women who desire permanent birth control (female sterilization)	FemBloc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of short-term and long-term adverse events in each arm	Safety: Incidence of short-term and long-term adverse events in each arm	1-5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sponsor	Medical Affairs & Clinical Development	Study Director

Locations

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