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Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

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ClinicalTrials.gov Identifier: NCT03056066
Recruitment Status : Unknown
Verified April 2018 by Spircare Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : February 17, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Spircare Ltd.

Study Description
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Brief Summary:
The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.

Condition or disease Intervention/treatment
COPD Asthma Pulmonary Fibrosis Device: Plethysmograph

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019
Groups and Cohorts
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Intervention Details:
  • Device: Plethysmograph
    A full Body Plethysmography examination

Outcome Measures
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Primary Outcome Measures :
  1. The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device [ Time Frame: September 2017 ]
    The primary outcome of the FRC and air way resistance of the Spircare device against the plethysmograph will be displayed as scatter plot. A linear regression and the R2 value will be display as well. The associated Bland-Altman plots comparing the FRC and airway resistance of the Spircare device to the plethysmograph with lines that represent width of 0.1 (±1.96*SD).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Phase I Health subjects without respiratory system disease.

Phase II Subjects which are referred to a Pulmonary Functional Testing in the Meir pulmonary unit.

Criteria

Inclusion Criteria:

  1. Signed Informed consent.
  2. Age≥18 year.
  3. Subject is cooperative and capable of following instructions.
  4. Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.

  5. Phase II: Chronic pulmonary patients with lung volume disorders:

    • COPD
    • Asthma
    • Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.

Exclusion Criteria:

  1. Subjects unable or unwilling to give informed consent.
  2. Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).
  3. History suggesting upper respiratory infection during the four weeks prior to testing
  4. Physical activity during 1 hour prior to the Study.
  5. Patients with a tracheostomy.
  6. Pregnant women.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056066


Locations
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Israel
"Meir" Medical Center
Kfar-Saba, Israel, 4428164
Sponsors and Collaborators
Spircare Ltd.
More Information
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Responsible Party: Spircare Ltd.
ClinicalTrials.gov Identifier: NCT03056066    
Other Study ID Numbers: DA-1
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases