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New Reusable Mask Design With Superior Filtration and Fit

NCT04826809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-07-07

Study results available
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Summary

This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic. This mask is theorized to be a superior alternative to other respirators currently used when one-time-use N95 masks are unavailable.

Conditions

Interventions

DEVICE

N95 mask

Standard 1870 N95 one time use mask

DEVICE

Nordell single E-100 layer mask

Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay

DEVICE

Nordell double E-100 layer mask

Nordell mask design using two layers of E-100 fabric

Sponsors & Collaborators

Principal Investigators

  • Janielle R Nordell, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2022-10-27
Completion
2022-10-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04826809 on ClinicalTrials.gov