NCT06418282 Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
| NCT ID | NCT06418282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Koya Medical, Inc. |
| Condition | Phlebolymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-05-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Frequently Asked Questions
Who can join the NCT06418282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Phlebolymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06418282 currently recruiting?
Yes, NCT06418282 is actively recruiting participants. Visit ClinicalTrials.gov or contact Koya Medical, Inc. to inquire about joining.
Where is the NCT06418282 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06418282 clinical trial?
NCT06418282 is sponsored by Koya Medical, Inc.. The trial plans to enroll 100 participants.