NCT04511390

Brief Summary

In times of crisis, diminishing supplies of personal protective equipment (PPE) in hospitals has forced both healthcare workers and the general population to reuse and clean PPE using anecdotal strategies which may weaken its effectiveness of preventing acquisition of airborne respiratory illnesses, such as COVID-19. There is therefore a great need to develop innovative measures to generate reusable PPE that can be safely cleaned and sterilized. A novel reusable injection molded respirator will be evaluated using qualitative and quantitative fit tests to assess overall fit and comfort.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

July 25, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

August 10, 2020

Last Update Submit

August 2, 2021

Conditions

Personal Protective Equipment

Outcome Measures

Primary Outcomes (1)

  • Success of fit testing

    Successful fit testing using an Occupational Safety and Health Administration (OSHA)-approved testing method testing method

    30 minutes

Secondary Outcomes (1)

  • User experience

    30 minutes

Study Arms (1)

Transparent, reusable respirator

EXPERIMENTAL

Transparent, reusable elastomeric respirator that has been designed to fit multiple different face sizes and shapes.

Device: Transparent, reusable respirator

Interventions

Transparent, reusable respiratorDEVICE

A novel respirator with dual N95 filter cartridges

Transparent, reusable respirator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare workers that have undergone successful fit test with N95 FFR within 1 year of the trial

You may not qualify if:

  • Facial hair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Central Study Contacts

Giovanni Traverso, MB, BChir, PhD

CONTACT

617-253-5726cgt20@mit.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 13, 2020

Study Start

July 25, 2020

Primary Completion

December 30, 2021

Study Completion

February 28, 2022

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations

US(3)