Status:

RECRUITING

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

Lead Sponsor:

Koya Medical, Inc.

Conditions:

Phlebolymphedema

Lymphedema

Eligibility:

All Genders

18-100 years

Phase:

NA

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

Detailed Description

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 Criteria

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

Key Trial Info

Start Date :

May 13 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06418282

Start Date

May 13 2024

End Date

December 31 2027

Last Update

March 31 2026

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Glenn Jacobowitz

New York, New York, United States, 10016