Recruiting

NPCD

Sponsor:

Koya Medical, Inc.

Code:

NCT06418282

Conditions

Phlebolymphedema

Lymphedema

Chronic Venous Insufficiency

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dayspring

Study Details

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

Phlebolymphedema

Lymphedema

Chronic Venous Insufficiency

Study ID

NCT06418282

Start date

May 13, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Diagnosis of chronic kidney disease with acute renal failure
  • Diagnosis of epilepsy
  • Subjects with poorly controlled asthma
  • Any condition where increased venous and lymphatic return is undesirable
  • Women who are pregnant, planning a pregnancy or nursing at study entry
  • Participation in any clinical trial of an investigational substance or device during the past 30 days

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Dayspring

NPCD

Primary outcome measure

  • Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events) [ Time Frame: 6 months ]
  • Mobility (daily steps using a pedometer) [ Time Frame: 6 months ]
  • Venous Clinical Severity Score (VCSS) [ Time Frame: 180 days ]

Central Contacts and Locations

Locations

Glenn Jacobowitz

Recruiting

New York, New York, United States, 10016

Contacts

Glenn Jacobowitz, MD

415-851-0337clinical@koyamedical.com

More Information

Sponsor

Koya Medical, Inc.

Last update posted

May 4, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Koya Medical, Inc. on 2026-05-04.