Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:25 AM
Study NCT ID:
NCT05175612
Status:
SUSPENDED
Last Update Posted:
2022-06-07
First Post:
2021-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device
Sponsor:
Healthy Networks
Organization:
Study Overview
Official Title:
Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device
Status:
SUSPENDED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
For sponsor reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate upper and lower respiratory tract infections (URTI and LRTI)
Detailed Description:
This is a prospective observational study comprised patients presenting with acute respiratory tract infection symptoms in primary care settings. Patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and LungPass device. Moreover, symptoms and anamnesis data, result of diagnostic questionnaire from the LungPass App, complete blood count, C-reactive protein, procalcitonin (PCT) level, SARS-CoV-2 PCR test and X-ray chest examination or CT chest (in case of preliminary clinical suspicion of LRTI). Patients will be followed up within 5-7 days and at the end of the disease in person or by phone for clinical course of the disease assessment to confirm the final diagnosis (URTI or LRTI). Final diagnosis will be considered as Gold standard for accuracy assessment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: