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Compression Device
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 (NILE Trial)
N/A
Waitlist Available
Research Sponsored by Koya Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Summary
To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
Eligible Conditions
- Swelling of the Arm
- Lymphedema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Arm Volume Maintenance or Improvement
LYMQOL (LYMphedema Quality of Life)
Secondary study objectives
Patient survey on preference
Safety/AEs
Therapy adherence tracking
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dayspring Active Wearable Compression DeviceExperimental Treatment1 Intervention
The Dayspring Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure full-arm compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.
Group II: Advanced Pneumatic Compression DeviceActive Control1 Intervention
A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.
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Who is running the clinical trial?
Koya Medical, Inc.Lead Sponsor
6 Previous Clinical Trials
383 Total Patients Enrolled
6 Trials studying Lymphedema
383 Patients Enrolled for Lymphedema