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Compression Device
Crossover Device (PCD or Dayspring - alternate to first group) for 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
Males and females ≥ 18 years of age
Willing to sign the informed consent and deemed capable of following the study protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
NILE Trial Summary
This study is evaluating whether a wearable compression device is as effective as an APCD.
Eligible Conditions
- Lymphedema
NILE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNILE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Arm Volume Maintenance or Improvement
LYMQOL (LYMphedema Quality of Life)
Secondary outcome measures
Patient survey on preference
Safety/AEs
Therapy adherence tracking
NILE 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
5 Previous Clinical Trials
333 Total Patients Enrolled
5 Trials studying Lymphedema
333 Patients Enrolled for Lymphedema
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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