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Tests treatment safety and results for Phlebolymphedema
Official title Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
ClinicalTrials.gov ID: NCT06418282
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Males and females ≥ 18 years of age
- Capable and willing to sign the informed consent and deemed capable of following the study protocol
- people must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of...
- people who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux
You likely can't join if
- 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...
- people 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.)
See the full eligibility criteria
- Males and females ≥ 18 years of age
- Capable and willing to sign the informed consent and deemed capable of following the study protocol
- people must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
- people who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux
- 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
- people 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.