NCT03433911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 1, 2018

Last Update Submit

February 24, 2026

Conditions

Contraception

Keywords

Permanent contraceptionBirth control

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

FemBloc

EXPERIMENTAL

Investigational device and procedure

Device: FemBloc

Control

ACTIVE COMPARATOR

Laparoscopic bilateral tubal sterilization

Procedure: Laparoscopic bilateral tubal sterilization

Interventions

FemBlocDEVICE

Treatment with FemBloc for women who desire permanent birth control (female sterilization)

FemBloc
Laparoscopic bilateral tubal sterilizationPROCEDURE

Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

Control

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

New Horizons Clinical Trials

Chandler, Arizona, 85224, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Altus Research Inc.

Lake Worth, Florida, 33461, United States

Location

Rosemark Womencare Specialists

Idaho Falls, Idaho, 83404, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Rutgers, The State University of New Jersey

Newark, New Jersey, 07103, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

University Hospitals Cleveland Medical Center

Beachwood, Ohio, 44122, United States

Location

Amy Brenner MD & Associates

Mason, Ohio, 45069, United States

Location

Chattanooga Medical Research LLC

Chattanooga, Tennessee, 37404, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Links

Study Officials

  • Sponsor

    Medical Affairs & Clinical Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 15, 2018

Study Start

February 2, 2018

Primary Completion

January 31, 2020

Study Completion

February 10, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(12)