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| ID | Type | Description | Link |
|---|---|---|---|
| OCR39724 | Other Identifier | UF Oncore |
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recruitment difficulty due to COVID recruitment difficulty due to covid
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This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD), most commonly used being High frequency vest airway clearance system (VEST) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis (CF) ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on Forced expiratory volume in 1 second (FEV1) 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIAPD-Portable Internal Airway Percussion device | Experimental | There will be an outpatient arm using the PIAPD-Portable Internal Airway Percussion Device. |
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| SACD-Standard Airway Clearance device | Active Comparator | There will be an Outpatient Arm using the SACD, VEST (High Frequency Chest Wall Oscillation VEST) Standard Airway Clearance Device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Airway Clearance device | Device | Subjects will be using their home standard airway clearance device, VEST (High Frequency Chest Wall Oscillation VEST) for 2 weeks followed by PIAPD. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation % by Pulse Oximetry | oxygen saturation will be obtained by home pulse oximeter device. | O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2 |
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Inclusion Criteria:
Exclusion Criteria:
FEV1 < 40% predictive
Pneumothorax
Hemoptysis
Coronavirus disease (COVID) 19 diagnosis within last 14 days
Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Delgado Villalta, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Medical Plaza Pulmonary Clinic | Gainesville | Florida | 32610 | United States |
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Only one patient was recruited to the study. The patient was outpatient. There were difficulties with recruitment related to COVID-19 pandemic, difficulties obtaining pulmonary function testing related to Covid-19 pandemic, limited staff.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Subjects will use Standard of Care (SCA) airway clearance Device (VEST) for 2 weeks followed by Interventional Airway Clearance Device (PIAPD) for 2 weeks. Forced Expiratory Volume in 1 Second (FEV1) will be measured by Smart One® portable home spirometer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SOC Airway Clearance Device ( VEST) |
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| PIAPD |
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only one patient was recruited. The patient participated as outpatient.
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| ID | Title | Description |
|---|---|---|
| BG000 | SACD-Standard Airway Clearance Device Followed by PIAPD | There will be an Outpatient Arm using the SACD for 2 weeks followed by PIAPD for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxygen Saturation % by Pulse Oximetry | oxygen saturation will be obtained by home pulse oximeter device. | Posted | Number | percentage of oxygen saturated hemoglobi | O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2 |
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The collection time was between June 17, 2021 to June 26, 2021 - please clarify this is a 4 week study
NO Adverse events reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vest Followed by PIADD | Vest airway clearance treatment for 2 weeks, followed by PIADD airway clearance treatment for 2 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Silvia Delgado Villalta | University of Florida | 7185684198 | silviadelgado@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2021 | Oct 28, 2024 | Prot_SAP_001.pdf |
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| 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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This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a PIAPD in patients with stable cystic fibrosis ages 6 -21 years. The primary hypothesis (Stated as Null) being that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD.
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| Portable Internal Airway Percussion device | Device | Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| 0 |
| 1 |
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| 1 |
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| 1 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |