Cystic Fibrosis, PulmonaryNCT03437811
Airway Clearance System (K031876) Phase IV Device Efficacy
An observational study of Cystic Fibrosis, Pulmonary, run by Mack Biotech, Corp. at 1 site in United States.
Trial summary
Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Pulmonary
- What is being tested?
- Electro Flo Percussor, Model 5000
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 1 Nov 2019
- Phase
- Observational
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 18 to 55 years of age, male or female.non-smokers
Who may be able to join
- Previously diagnosed with cystic fibrosis (mild, moderate or severe)
- Prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance
- Physically able to perform self-treatment or treatment by an at home medical provider
Who cannot join
- History of tobacco use
- History of excessive alcohol consumption, more than 2 drinks per day, 10 per week
- Any other medical condition that would preclude use of an airway clearance device
- Previously diagnosed with major cardiological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Med Systems' Electro Flo Percussor Model 5000, Airway Clearance System, for Pulmonary Clearance of Secretions.
Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of the thorax. The trial period shall be 21 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.
Read the detailed description
Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876), Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ( I ) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
- Conditions
- Cystic Fibrosis, Pulmonary
- Being tested
- Electro Flo Percussor, Model 5000
- Keywords
- airway clearance system, cystic fibrosis, lung secretion clearance
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro Flo Percussor, Model 5000Device
FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active arm, Electro Flo Percussor, Model 5000 airway clearance system for daily basis as needed (pro re nata). Receives: Device: Electro Flo Percussor, Model 5000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of oxygen levels in the blood (pulse oximetry).
SpO2 will be monitored using the standard pulse oximeter system (K131111).
Measured: Change from baseline up to 3.5 hours.
Secondary outcomes (1)
Percentage change of lung function
Evaluate expiratory forced vital capacity (FVC) and forced expiratory volume (FEV1) will be monitored with standard spirometer.
Measured: Change from baseline up to 3.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start28 Feb 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis, PulmonaryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mack Biotech, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Leigh J. Mack, Mack Biotech, Corp.
- Investigators
- Leigh J Mack, MD, PhD, CPI, Principal investigator, Mack Biotech, Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437811
- Sponsor's protocol ID
- 201801MEDSystems
- Status last verified
- Apr 2020
- First submitted
- 17 Jan 2018
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Available final outcomes for complete study shall be available December 31, 2019. No individual specific outcomes shall be shared.
Publications
Main E, Prasad A, Schans C. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD002011. doi: 10.1002/14651858.CD002011.pub2.
PubMed 15674888Oermann CM, Sockrider MM, Giles D, Sontag MK, Accurso FJ, Castile RG. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study. Pediatr Pulmonol. 2001 Nov;32(5):372-7. doi: 10.1002/ppul.1146.
PubMed 11596162
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Med Systems' Electro Flo Percussor Model 5000, Airway Clearance System, for Pulmonary Clearance of Secretions.
- ClinicalTrials.gov ID
- NCT03437811
- Acronym / sponsor ID
- 201801MEDSystems
- Conditions
- Cystic Fibrosis, Pulmonary
- Keywords
- airway clearance system, cystic fibrosis, lung secretion clearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mack Biotech, Corp.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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.
Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of the thorax. The trial period shall be 21 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.
Detailed description
Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876), Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ( I ) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | – | Device: Electro Flo Percussor, Model 5000Active arm, Electro Flo Percussor, Model 5000 airway clearance system for daily basis as needed (pro re nata). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18 to 55 years of age, male or female.non-smokers
Key inclusion criteria (3 listed)
- Previously diagnosed with cystic fibrosis (mild, moderate or severe)
- Prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance
- Physically able to perform self-treatment or treatment by an at home medical provider
Key exclusion criteria (4 listed)
- History of tobacco use
- History of excessive alcohol consumption, more than 2 drinks per day, 10 per week
- Any other medical condition that would preclude use of an airway clearance device
- Previously diagnosed with major cardiological disease
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 |
|---|---|---|
| Electro Flo Percussor, Model 5000FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1 | Device | Active Treatment |
Primary outcome
Percentage change of oxygen levels in the blood (pulse oximetry).
Time frame: Change from baseline up to 3.5 hours.
SpO2 will be monitored using the standard pulse oximeter system (K131111).
1 secondary outcome
Percentage change of lung function
Time frame: Change from baseline up to 3.5 hours
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 10 Apr 2020.
- Background: PubMed 15674888Main E, Prasad A, Schans C. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD002011. doi: 10.1002/14651858.CD002011.pub2.
- Background: PubMed 11596162Oermann CM, Sockrider MM, Giles D, Sontag MK, Accurso FJ, Castile RG. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study. Pediatr Pulmonol. 2001 Nov;32(5):372-7. doi: 10.1002/ppul.1146.
- Cleared device informationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Available final outcomes for complete study shall be available December 31, 2019. No individual specific outcomes shall be shared.
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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.
Leigh J Mack, MD, PhD, CPI principal investigator
Mack Biotech, Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, Pulmonary, run by Mack Biotech, Corp. at 1 site in United States.
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 3 inclusion and 4 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 10 Apr 2020. 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 United States. 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?
Percentage change of oxygen levels in the blood (pulse oximetry). (time frame: Change from baseline up to 3.5 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03437811, which also lists 2 linked publications.
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 10 Apr 2020.