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A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring TLC (total lung capacity) compared to TLC measured by standard body plethysmography using the ZAN 500. The study will be conducted as a prospective two-arm, open, randomized comparative study.
This study is a prospective, multi-centered, randomized, comparative study designed to demonstrate substantially equivalence performance of the proposed device, the PulmOne MiniBoxPFT, to its predicate device, the ZAN500, for the measurement of total lung capacity (TLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PulmOne MiniBox PFT | Experimental | Total Lung Capacity (TLC) testing with PulmOne MiniBoxPFT |
|
| ZAN500 | Active Comparator | Total Lung Capacity (TLC) testing with ZAN500. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Lung Capacity (TLC) testing | Device | Comparison of TLC results |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Lung Capacity (TCL) | 1 year |
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Inclusion Criteria:
Subject is at least 18 years of age.
Subject is cooperative and capable of following instructions.
Healthy subjects:
Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mordechai Yigla, MD | Rambam University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam University Medical Center | Haifa | Israel |
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| ID | Term |
|---|---|
| D014109 | Total Lung Capacity |
| ID | Term |
|---|---|
| D008176 | Lung Volume Measurements |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
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| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |