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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.

Tracking Information
First Submitted Date February 13, 2017
First Posted Date February 17, 2017
Last Update Posted Date May 1, 2018
Actual Study Start Date July 31, 2017
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2017)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
Official Title Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • COPD Asthma
  • Pulmonary Fibrosis
Intervention Device: Plethysmograph
A full Body Plethysmography examination
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 16, 2017)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03056066
Other Study ID Numbers DA-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Spircare Ltd.
Study Sponsor Spircare Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account Spircare Ltd.
Verification Date April 2018