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cPSTA System CADLAD Study

NCT02784197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2622

Last updated 2019-06-12

No results posted yet for this study

Summary

This study is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient.

Conditions

Interventions

DEVICE

Phase Signal Recorder

The cPSTA System is a medical device system that uses passive tomography to analyze a patient's phase space data to identify the presence of significant coronary artery disease. The cPSTA System consists of several components that work together to obtain, transmit, analyze the data, and display the results, including the Phase Signal Acquisition System (PSAQ System), which is the Phase Signal Recorder (PSR) and the Phase Signal Data Repository (PSDR); analytical software; and secure web portal. For this study only the PSAQ System is used by the clinical site for the purposes of acquiring and transmitting the signal.

Sponsors & Collaborators

  • Analytics For Life

    lead INDUSTRY

Principal Investigators

  • William E Sanders, Jr., MD MBA FHRS · Analytics For Life

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-12-31
Completion
2018-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784197 on ClinicalTrials.gov