Back to resultsMeasurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
Primary Purpose
TLC in Patients With and Without Respiratory System Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Total Lung Capacity (TLC) testing
Sponsored by
About this trial
This is an interventional diagnostic trial for TLC in Patients With and Without Respiratory System Disease focused on measuring Total Lung Capacity
Eligibility Criteria
Inclusion Criteria:
- Subject is at least 18 years of age.
- Subject is cooperative and capable of following instructions.
Healthy subjects:
- Never smokers.
- No known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
- BMI < 35.
- No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea, chronic cough, wheezing or phlegm).
- No history suggesting upper respiratory infection during the three weeks prior to testing.
- Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.
Exclusion Criteria:
- Subjects who are unable to satisfactorily perform routine, full lung function testing(due to non-compliance or claustrophobia).
- Subjects unable or unwilling to give informed consent.
- Subjects who have performed any significant physical activity during 1 hour prior to the Study.
- Patients with a tracheostomy.
- Pregnant women.
Sites / Locations
- Rambam University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PulmOne MiniBox PFT
ZAN500
Arm Description
Total Lung Capacity (TLC) testing with PulmOne MiniBoxPFT
Total Lung Capacity (TLC) testing with ZAN500.
Outcomes
Primary Outcome Measures
Total Lung Capacity (TCL)
Secondary Outcome Measures
Full Information
NCT ID
NCT01952431
First Posted
June 13, 2013
Last Updated
November 9, 2014
Sponsor
PulmOne Advanced Medical Devices, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01952431
Brief Title
Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
Official Title
Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PulmOne Advanced Medical Devices, Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TLC in Patients With and Without Respiratory System Disease
Keywords
Total Lung Capacity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PulmOne MiniBox PFT
Arm Type
Experimental
Arm Description
Total Lung Capacity (TLC) testing with PulmOne MiniBoxPFT
Arm Title
ZAN500
Arm Type
Active Comparator
Arm Description
Total Lung Capacity (TLC) testing with ZAN500.
Intervention Type
Device
Intervention Name(s)
Total Lung Capacity (TLC) testing
Other Intervention Name(s)
TLC
Intervention Description
Comparison of TLC results
Primary Outcome Measure Information:
Title
Total Lung Capacity (TCL)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is at least 18 years of age.
Subject is cooperative and capable of following instructions.
Healthy subjects:
Never smokers.
No known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
BMI < 35.
No persisting respiratory symptoms during the last 12 months. (e.g., dyspnea, chronic cough, wheezing or phlegm).
No history suggesting upper respiratory infection during the three weeks prior to testing.
Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.
Exclusion Criteria:
Subjects who are unable to satisfactorily perform routine, full lung function testing(due to non-compliance or claustrophobia).
Subjects unable or unwilling to give informed consent.
Subjects who have performed any significant physical activity during 1 hour prior to the Study.
Patients with a tracheostomy.
Pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai Yigla, MD
Organizational Affiliation
Rambam University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam University Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
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