NCT03067272

Brief Summary

Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 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 17, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
Last Updated

May 9, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 17, 2017

Last Update Submit

May 5, 2023

Conditions

Contraception

Keywords

Permanent contraceptionBirth control

Outcome Measures

Primary Outcomes (1)

  • Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure

    Evaluated up to 3 months after the FemBloc treatment procedure

    5 months

Other Outcomes (2)

  • Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Confirmation test

    5 months

  • Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Biopolymer

    5 months

Study Arms (1)

FemBloc® Permanent Contraceptive System

EXPERIMENTAL

Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.

Device: FemBloc® Permanent Contraceptive System

Interventions

FemBloc® Permanent Contraceptive SystemDEVICE

The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Biopolymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).

FemBloc® Permanent Contraceptive System

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
  • Agreement to use temporary birth control (excluding IUC) until documented occlusion
  • Sexually active (minimum of 4 coital acts per month) with male partner who is not known or suspected to be sterile
  • At low risk for sexually transmitted infection and / or monogamous
  • Reasonably certain subject is not pregnant at time of screening and procedure visits
  • Willing to accept the risk of pregnancy while relying solely on FemBloc for contraception
  • Signs informed consent agreeing to the protocol requirements and is able to meet the trial schedule

You may not qualify if:

  • Uncertainty about the desire to end fertility
  • Suspected or confirmed pregnancy
  • Prior tubal surgery
  • Uterine anomaly such as unicornuate, bicornuate, arcuate, septate, and didelphic
  • Known endometrial or myometrial conditions (e.g. submucous leiomyoma) or uterine position (e.g. retroflexion or anteflexion) that would interfere with insertion tube midline fundal placement, access to uterine cornua, or lateral deployment of the catheters
  • Any condition which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented
  • Active or untreated pelvic infection
  • Presence or suspicion of gynecologic malignancy
  • Any condition or medical treatment (e.g. systemic corticosteroids or chemotherapy) that compromises immune system
  • Post-partum or pregnancy termination \<6 weeks of scheduled procedure
  • Complicated IUC removal on the day of FemBloc treatment (e.g. use of intracavitary instrument for removal, bleeding, excessive pain)
  • Scheduled to undergo concomitant intrauterine procedures at the time of FemBloc treatment or planning any uterine procedure within the 3 months after treatment
  • Known hypersensitivity to cyanoacrylate or formaldehyde
  • Prior history of ectopic pregnancy
  • Abnormal uterine bleeding of unknown etiology
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Altus Research Inc.

Lake Worth, Florida, 33461, United States

Location

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York, 10032, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Chattanooga Medical Research

Chattanooga, Tennessee, 37404, United States

Location

Study Officials

  • Study Director

    Sponsor Clinical Affairs

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 1, 2017

Study Start

March 15, 2017

Primary Completion

February 27, 2018

Study Completion

March 14, 2023

Last Updated

May 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)