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)
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1
Glenn Jacobowitz
New York, New York, United States, 10016