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The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up Validation studies that will assess device accuracy using the new measurement collection methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generally healthy subjects with no known cancer disorder |
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| Subjects with a pathological diagnosis of cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProLung System | Device | Non-invasive bioconductance measurements |
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| Measure | Description | Time Frame |
|---|---|---|
| Establish the ProLung Test measurement collection protocol for future studies. | The study will evaluate several data collection methodologies including the China CFDA Study method which utilizes diaphoretic electrodes as the reference electrode at measurement point locations and other methods using brass reference electrode at point locations. In addition, the benefits of obtaining multiple repeat measurements will be evaluated. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of the ProLung Test procedures | Adverse events will be recorded and following the ProLung Test, subjects will be asked to complete a brief questionnaire regarding their experience and perception of the procedure. The questions are:
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Inclusion Criteria:
7 2.0 Study Objectives 2.1 Objectives and Aims The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure and identify approaches that may be useful in evaluating other cancers in addition to lung cancer. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up cancer validation studies that will assess device accuracy using the new measurement collection methods.
The Specific Aim of this study:
Subjects who meet all of the following criteria may be enrolled in this Study:
Exclusion Criteria:
The following criteria will disqualify a subject from enrollment into this Study:
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Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Garff | Contact | 385.501.7002 | mag@prolunginc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Pulmonary Associates | Recruiting | Encinitas | California | 92024 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 1 day |
| Loyola Medical University | Recruiting | Maywood | Illinois | 60153 | United States |
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| Ogden Regional Medical Center | Recruiting | Ogden | Utah | 84405 | United States |
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| Michael Garff | Recruiting | Salt Lake City | Utah | 84103 | United States |
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