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

November 9, 2014 updated by: PulmOne Advanced Medical Devices, Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PulmOne MiniBox PFT
Total Lung Capacity (TLC) testing with PulmOne MiniBoxPFT
Device: Total Lung Capacity (TLC) testing
Comparison of TLC results
Other Names:
  • TLC
Active Comparator: ZAN500
Total Lung Capacity (TLC) testing with ZAN500.
Device: Total Lung Capacity (TLC) testing
Comparison of TLC results
Other Names:
  • TLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Lung Capacity (TCL)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PulmOne Advanced Medical Devices, Ltd.

Investigators

  • Principal Investigator: Mordechai Yigla, MD, Rambam University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 9, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PulmOne-1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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