NCT04659564

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Koya Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Related Lymphedema
• Lymphedema of Upper Arm
• Lymphedema
• Quality of Life

Interventions

Type	Name	Description
DEVICE	User of Dayspring device	The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system.

Timeline

• Start date: 2020-08-05
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2020-12-09
• Last updated: 2021-06-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study