Clinical trial · Interventional
A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
A Pilot Cross-Over Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
NCT05485454CI-TRIAL-00060866completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema, Lower Limb | — | UNRESOLVED | — |
| Lymphedema of Leg | — | UNRESOLVED | — |
| Lymphedema Primary | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aria Health Aria Free | Device | — | UNRESOLVED |
| A Traditional PCD | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aria Health Aria Free
- description
- An Aria Free therapy session on the study lower limb.
- interventionNames
- Device: Aria Health Aria Free
- type
- ACTIVE_COMPARATOR
- label
- Traditional PCD
- description
- A therapy session using the traditional PCD on the study lower limb.
- interventionNames
- Device: A Traditional PCD
Primary outcomes (1)
- measure
- Satisfaction and Preference
- timeFrame
- Satisfaction and Preference ratings will be assessed during the only study visit: Visit 1/Day 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.