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

NCT06418282 | Recruiting FDA Device

• 1 other identifier: KCT 013 (GRANDE)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Venous Insufficiency; Phlebolymphedema; Lymphedema

Outcome Measures

Primary Outcomes (3)

• Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)

  Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)

  6 months

• Mobility (daily steps using a pedometer)

  Mobility (daily steps using a pedometer)

  6 months

• Venous Clinical Severity Score (VCSS)

  Venous Clinical Severity Score (VCSS)

  180 days

Secondary Outcomes (2)

• Lower extremity edema response (limb girth reduction)

  6 months

• Safety/Adverse Events

  6 months

Study Arms (1)

Dayspring, Non-Pneumatic Active Compression Device (NPCD)

EXPERIMENTAL

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.

Device: Dayspring

Interventions

Dayspring DEVICE

NPCD

Dayspring, Non-Pneumatic Active Compression Device (NPCD)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
• Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
• Non-ambulatory individuals
• Female: BMI \> 34 (5'4", 200 lbs.)
• Male: BMI \> 34 (5'9", 230 lbs.)
• (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
• Diagnosis of lipedema
• Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
• Diagnosis of acute infection (in the last four weeks)
• Diagnosis of active/open wound/ulcer
• Diagnosis of acute thrombophlebitis (in last 2 months)
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled/uncompensated)

Sponsors & Collaborators

• Koya Medical, Inc.: lead

Study Sites (1)

Glenn Jacobowitz

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2025-12

Locations

US (1)