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Thora-3DI™ for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)

NCT03492359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-05-07

No results posted yet for this study

Summary

To demonstrate differences in tidal breathing patterns measured by SLP(Structured Light Plethysmography) between healthy subjects and COPD (chronic obstructive pulmonary disease). The correlation between SLP parameters and standard lung function parameters measured by body box and spirometry will also be assessed. Trends in SLP breathing patterns between the different GOLD (Global Initiative for Chronic Obstructive Lung Disease) stages of COPD, and between those and healthy subjects, will be investigated to assess whether SLP can detect differences between groups.

Conditions

  • Chronic Obstructive Pulmonary Disease

Interventions

DEVICE

Thora-3Di

Device that uses a grid of structured light to measure chest and abdominal wall movement

DEVICE

Body Plethysmography

A pulmonary function test (PFT) for measuring total lung volume.

DEVICE

Spirometry

A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.

Sponsors & Collaborators

  • Pneumacare Ltd

    collaborator INDUSTRY

  • Landon Pediatric Foundation

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-10-01
Completion
2019-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03492359 on ClinicalTrials.gov