NCT01599195

Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound.

Detailed description

Recorded signals are stored on a laptop computer. The signals later undergo Fourier analysis are then compared to the findings on carotid ultrasoud as to degree of stenosis. Subjects with high grade stenosis in which no bruit was ascultated but in which carotid ultrasound data suggests a bruit may be present are studied for soft /inaudible bruits. When available, data will be correlated to CT/conventional angiographic studies.

Conditions

• Carotid Stenosis
• Femoral Arterial Stenosis
• Carotid Bruit Asymptomatic
• Carotid Murmur

Interventions

Type	Name	Description
DEVICE	AudioDoc	AudioDoc will be used to identify the carotid and femoral bruit

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-09-01
• Completion: 2017-01-01
• First posted: 2012-05-15
• Last updated: 2017-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study