An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Males and females ≥ 18 years of age
• Capable and willing to sign the informed consent and deemed capable of following the study protocol
• Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
• Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux
Locations
United States
New York
Glenn Jacobowitz
RECRUITING
New York
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 100
Treatments
Experimental: Dayspring, Non-Pneumatic Active Compression Device (NPCD)
The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure 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.
Related Therapeutic Areas
Sponsors
Leads: Koya Medical, Inc.