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

Lymphedema Clinical Trial

— GRANDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418282
• Other study ID #: KCT 013 (GRANDE)
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: Koya Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Lymphedema
• Venous Insufficiency

Intervention

Device:
• Dayspring
NPCD

Locations

Country	Name	City	State
United States	Glenn Jacobowitz	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Koya Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphedema Overall Quality of Life and Patient Survey	The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 6	6 months
Primary	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
Primary	Mobility (daily steps using a pedometer)	Mobility (daily steps using a pedometer)	6 months
Secondary	Lower extremity edema response (limb girth reduction)	Lower extremity edema response (limb girth reduction)	6 months
Secondary	LE Functional Index (LEFI)	LE Functional Index (LEFI)	6 months
Secondary	Venous Clinical Severity Score (VCSS)	Venous Clinical Severity Score (VCSS) scored on severity from None (0), Mild (1), Moderate (2) to Severe (3). Higher score means a worse outcome	6 months
Secondary	Safety/Adverse Events	As assessed by reported adverse events	6 months