Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01952431
  4. Details
NCT01952431 Clinical Trial

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

TLC in Patients With and Without Respiratory System Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01952431
Other study ID # PulmOne-1.0
Secondary ID
Status Completed
Phase N/A
First received June 13, 2013
Last updated November 9, 2014
Start date April 2013
Est. completion date September 2013

Study information
Verified date September 2013
Source PulmOne Advanced Medical Devices, Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Total Lung Capacity (TLC) testing
Comparison of TLC results

Locations
Country Name City State
Israel Rambam University Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
PulmOne Advanced Medical Devices, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Lung Capacity (TCL) 1 year No