Evaluation of the EasySense System in Congestive Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03237923|
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : August 3, 2017
|Condition or disease||Intervention/treatment|
|Congestive Heart Failure||Device: EasySense device|
Across the globe, Congestive Heart Failure (CHF) continues to be the leading cause of mortality and hospitalizations in the 21st century. Despite advancements, prognosis often remains poor and mortality high. Congestive Heart Failure diagnoses are often characterized by frequent hospitalizations and re-admissions, and early detection of pulmonary edema, a chief characteristic of worsening heart failure, may have positive implications in patients' quality of life and frequency of hospitalizations. The EasySense device is a non-invasive device designed to measure lung fluid in patients with CHF. Similar to ultrasound technology, the device uses radiofrequency waves to assess fluid status. The device is placed on the bare skin of the chest and held in place for approximately 60 seconds to obtain a reading.
This study seeks to evaluate the efficacy of the EasySense system in measuring lung fluid volume. Seventy-five patients are sought for enrollment. Patients will be enrolled during their hospital stay, and will be asked to maintain daily EasySense measurements, in addition to other measurements, for thirty days post-discharge.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Evaluation of the EasySense System in Congestive Heart Failure|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
- Device: EasySense device
Implementation of EasySense device during hospitalization and daily post-discharge for thirty days.
- Comparison of volume status to EasySense measurements [ Time Frame: 30 days ]Patient volume status extracted from medical records will be compared to what the EasySense device measures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237923
|Contact: Sitaramesh Emani, MDemail@example.com|
|Contact: Christina Athas, MPHfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Christina Athas, MPH email@example.com|
|Contact: Brittany Monk firstname.lastname@example.org|
|Principal Investigator: Sitaramesh Emani, MD|