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Safety and Usability of the LUMENA Non-invasive Ventilation Mask

NCT05479773 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-15

No results posted yet for this study

Summary

Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.

Conditions

Interventions

DEVICE

Standard NIV mask

The hospital standered NIV mask

DEVICE

Lumena NIV mask

aerosol-reducing mask

Sponsors & Collaborators

  • Inspir Labs Ltd.

    lead INDUSTRY

Principal Investigators

  • Nimrod Adi, Mr · Head of ICU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2023-04-01
Completion
2023-06-22

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT05479773 on ClinicalTrials.gov