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Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study — DAYSPRING  

Quality of Life Clinical Trial

Official title:
Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study

Clinical Trial Summary

An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. The following endpoints are examined: 1. Improvement in QoL in subject with upper-extremity edema after 28 days as measured by the LYMQOL disease-specific validated assessment tool. 2. Arm volume maintenance or improvement as measured prior to and after 28 days of device use. 3. Safety as assessed by reported adverse events 4. Patient satisfaction as measured by visual analog scale (VAS) and survey at the end of the study; and 5. Adherence to therapy as measured with a smart phone app.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04659564
Study type Interventional
Source Koya Medical, Inc.
Contact
Status Completed
Phase N/A
Start date August 5, 2020
Completion date May 28, 2021
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