Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01952431

Enrollment

100

Registered

2013-09-30

Start date

2013-04-30

Completion date

2013-09-30

Last updated

2014-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TLC in Patients With and Without Respiratory System Disease

Keywords

Total Lung Capacity

Brief summary

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.

Detailed description

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).

Interventions

DEVICETotal Lung Capacity (TLC) testing

Comparison of TLC results

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Subject is at least 18 years of age. 2. Subject is cooperative and capable of following instructions. 3. Healthy subjects: 1. Never smokers. 2. No known history of respiratory, cardiovascular, hepatic, renal or metabolic disease. 3. BMI \< 35. 4. No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea, chronic cough, wheezing or phlegm). 5. No history suggesting upper respiratory infection during the three weeks prior to testing. 4. Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.

Exclusion criteria

1. Subjects who are unable to satisfactorily perform routine, full lung function testing(due to non-compliance or claustrophobia). 2. Subjects unable or unwilling to give informed consent. 3. Subjects who have performed any significant physical activity during 1 hour prior to the Study. 4. Patients with a tracheostomy. 5. Pregnant women.

Design outcomes

Primary

Measure	Time frame
Total Lung Capacity (TCL)	1 year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026