TLC in Patients With and Without Respiratory System DiseaseNCT01952431
Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
A study testing Total Lung Capacity (TLC) testing in people with TLC in Patients With and Without Respiratory System Disease, run by PulmOne Advanced Medical Devices, Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- TLC in Patients With and Without Respiratory System Disease
- What is being tested?
- Total Lung Capacity (TLC) testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- Total Lung Capacity (TLC) testing
- Keywords
- Total Lung Capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Lung Capacity (TLC) testingDevice
Also called TLC
Comparison of TLC results
| Study group | Role | What they receive |
|---|---|---|
| PulmOne MiniBox PFT | Experimental | Total Lung Capacity (TLC) testing with PulmOne MiniBoxPFT Receives: Device: Total Lung Capacity (TLC) testing |
| ZAN500 | Active comparator | Total Lung Capacity (TLC) testing with ZAN500. Receives: Device: Total Lung Capacity (TLC) testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Lung Capacity (TCL)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TLC in Patients With and Without Respiratory System DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulmOne Advanced Medical Devices, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mordechai Yigla, MD, Principal investigator, Rambam University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952431
- Sponsor's protocol ID
- PulmOne-1.0
- Status last verified
- Sep 2013
- First submitted
- 13 Jun 2013
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)
- ClinicalTrials.gov ID
- NCT01952431
- Acronym / sponsor ID
- PulmOne-1.0
- Keywords
- Total Lung Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PulmOne Advanced Medical Devices, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PulmOne MiniBox PFT | Experimental | Device: Total Lung Capacity (TLC) testingTotal Lung Capacity (TLC) testing with PulmOne MiniBoxPFT |
| ZAN500 | Active comparator | Device: Total Lung Capacity (TLC) testingTotal Lung Capacity (TLC) testing with ZAN500. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is at least 18 years of age.
- Subject is cooperative and capable of following instructions.
- Healthy subjects:
- Patients with known disease affecting the respiratory system, with previous documentation of obstructive, restrictive, or mixed obstructive plus restrictive ventilatory abnormality.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Lung Capacity (TLC) testingAlso: TLCComparison of TLC results | Device | PulmOne MiniBox PFT, ZAN500 |
Primary outcome
Total Lung Capacity (TCL)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mordechai Yigla, MD principal investigator
Rambam University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Lung Capacity (TLC) testing in people with TLC in Patients With and Without Respiratory System Disease, run by PulmOne Advanced Medical Devices, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Lung Capacity (TCL) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.