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
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
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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