NCT04908254

A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema

A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Koya Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)

Detailed description

A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Conditions

• Lymphedema
• Lymphedema of Upper Arm
• Lymphedema, Breast Cancer

Interventions

Type	Name	Description
DEVICE	Crossover Device (PCD or Dayspring - alternate to first group)	Cross over arms after a month of use and a month of washout period

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-06-01
• Last updated: 2025-12-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study