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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Active arm, Electro Flo Percussor, Model 5000 airway clearance system for daily basis as needed (pro re nata). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro Flo Percussor, Model 5000 | Device | FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of oxygen levels in the blood (pulse oximetry). | SpO2 will be monitored using the standard pulse oximeter system (K131111). | Change from baseline up to 3.5 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of lung function | Evaluate expiratory forced vital capacity (FVC) and forced expiratory volume (FEV1) will be monitored with standard spirometer. | Change from baseline up to 3.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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18 to 55 years of age, male or female.non-smokers
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| Name | Affiliation | Role |
|---|---|---|
| Leigh J Mack, MD, PhD, CPI | Mack Biotech, Corp. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MED Systems, Inc. | San Diego | California | 92117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15674888 | Background | 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. | |
| 11596162 | Background | Oermann 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. |
| Label | URL |
|---|---|
| Cleared device information | View source |
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Available final outcomes for complete study shall be available December 31, 2019. No individual specific outcomes shall be shared.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 29, 2020 | |
| Reset | Jul 16, 2020 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2017 | Feb 12, 2018 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 15, 2018 | Mar 21, 2019 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2018 | Apr 22, 2019 | ICF_004.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2020 | Jul 16, 2020 |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |