Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

Part of paid clinical trials in New York, New York.

Sponsor
Koya Medical, Inc.
Study ID
NCT06418282
Status
Recruiting
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Conditions

  • Chronic Venous Insufficiency
  • Lymphedema
  • Phlebolymphedema

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Dayspring — DEVICE
    NPCD

Study Details

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

Key Dates

Start date
May 13, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Glenn JacobowitzNew YorkNew York10016
Glenn Jacobowitz, MD
[email protected]
415-851-0337

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By research site
Glenn Jacobowitz· New York, NY

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