A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema (NCT05485454) | Clinical Trial Compass
CompletedNot Applicable
A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
United States20 participantsStarted 2022-06-11
Plain-language summary
This study will aim to undertake a preference evaluation comparing the Aria Health Aria Free™ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another. Twenty (20) subjects will be enrolled on this study at one study site in Houston, Texas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel
* A diagnosis of unilateral or bilateral lower limb lymphedema
* A physician's prescription for use of a pneumatic compression device
* Able to provide written informed consent
* Patient can read and comprehend English
* Study leg must be within fit range of the Aria Free Garment (Ankle Max = 35cm/13.78in; Thigh Max = 80cm/34.49in)
Exclusion Criteria:
* Subject undergoing cancer treatment
* Subject has active lower limb wounds
* Subject is pregnant or trying to become pregnant
* History of pulmonary edema or decompensated congestive heart failure
* Subject has any condition in which increased venous and lymphatic return is undesirable
* Subject has inbuilt electrical stimulator, e.g., cardiac pacemaker
* Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
* Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene)
* Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Satisfaction and Preference
Timeframe: Satisfaction and Preference ratings will be assessed during the only study visit: Visit 1/Day 1.