NCT05485454

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research study is studying the preference of the compact Aria Health Aria Free™ Pneumatic Compression System ('Aria Free,' 'Aria') as a treatment for Lower Limb Lymphedema when compared to a traditional pneumatic compression device. A pneumatic compression device is also known as a 'PCD.' Both PCDs used in this study have been approved by United States Food and Drug Administration (FDA) for the treatment of lower limb lymphedema and are Code E0651 pneumatic compression devices, as defined by the Centers for Medicare \& Medicaid Services (CMS) under The Healthcare Common Procedure Coding System (HCPCS) for Durable Medical Equipment (DME). Subjects participating in this study are asked to use each PCD for a short therapy session and then answer a series of questionnaires regarding their experience with the devices. Participation in this study requires one clinic visit that will last about two (2) hours. At the beginning of the visit, the Investigator will ask each subject a series of questions to collect demographic data, and medical and pneumatic compression device usage history. The Investigator will then ask the subject to 'inspect' (touch and handle) the two PCDs used in this study and ask a few questions about the subject's opinion of the two devices based on this inspection. The Investigator will then guide the subject through completion of two (2) thirty (30) minute therapy sessions, one session using the Aria and the other session using the traditional PCD. The order in which the sessions are completed will be random, like the flip of a coin. Before and after each therapy session, the Investigator will complete a series of measurements and take photographs of the subject's lower limbs. The Investigator will also assess the subject's skin and tissue health after each intervention. Subjects will also be asked to complete questionnaires after each therapy session that will ask about subjective satisfaction with and preference between the two devices. Once the study visit has been completed, the subject will have completed the study and may return to his/her usual standard of care activities for treating his/her lower limb lymphedema.

Conditions

• Lymphedema of Leg
• Lymphedema
• Lymphedema, Secondary
• Lymphedema Primary
• Lymphedema, Lower Limb

Interventions

Type	Name	Description
DEVICE	Aria Health Aria Free	An in-clinic therapy session with the Aria Free for a duration of 30 minutes under the direct supervision of the Principal Investigator.
DEVICE	A Traditional PCD	An in-clinic therapy session with the traditional PCD for a duration of 30 minutes under the direct supervision of the Principal Investigator.

Timeline

• Start date: 2022-06-11
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2022-08-03
• Last updated: 2022-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study