Precision of IMED-4 Lung Fluid Measurements

Completed

• Conditions: Dyspnea; Acute Heart Failure Syndrome; Pulmonary Congestion

• Registration Number: NCT02187770
• Lead Sponsor: Intersection Medical, Inc.

Brief Summary

The purpose of this study is to determine if IMED-4 recordings have sufficient precision to detect a clinically significant change in lung fluid status in acute heart failure syndrome with pulmonary congestion.

Detailed Description

The study will evaluate if the IMED-4 system has the precision to detect a clinically significant change in lung fluid status for patients with confirmed acute heart failure syndrome with pulmonary congestion. Changes in lung fluid in acute heart failure syndrome are difficult to diagnose and evaluate.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Primary Completion: 2015-09
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung Fluid Status	Up to 1 year	IMED 4 is a new device to measure lung fluid status by assessing how wet or dry the lungs are

Trial Locations

Locations (3)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Mass General Hospital; 🇺🇸 Boston, Massachusetts, United States