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Status unknownNCT03056066Updated May 1, 2018

Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

An observational study in COPD Asthma and Pulmonary Fibrosis, sponsored by Spircare Ltd.. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Spircare Ltd. · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • COPD Asthma
  • Pulmonary Fibrosis

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03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's planned enrollment of 90 is below the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.

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Lead sponsor

This is the only study on the registry with Spircare Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Interventions

  • DevicePlethysmograph

    A full Body Plethysmography examination

06

What researchers measure

Primary outcomes

  1. The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device

    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).

    Time frame: September 2017

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Study locations

1 site
  • "Meir" Medical Center
    Kfar-Saba, 4428164, Israel
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03056066
Lead sponsor
Spircare Ltd.
Responsible party
Sponsor
First posted
Feb 17, 2017
Start date
Jul 31, 2017
Primary completion
Nov 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
May 1, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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