A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema

NCT ID: NCT05485454

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-11
• Study Completion Date: 2022-07-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Aria Health Aria Free

An Aria Free therapy session on the study lower limb.

Group Type: ACTIVE_COMPARATOR

Aria Health Aria Free

Intervention Type: DEVICE

An in-clinic therapy session with the Aria Free for a duration of 30 minutes under the direct supervision of the Principal Investigator.

Traditional PCD

A therapy session using the traditional PCD on the study lower limb.

Group Type: ACTIVE_COMPARATOR

A Traditional PCD

Intervention Type: DEVICE

An in-clinic therapy session with the traditional PCD for a duration of 30 minutes under the direct supervision of the Principal Investigator.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lymphatic Solutions, LLC

UNKNOWN

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise M Baylor, CLT-LANA

Role: PRINCIPAL_INVESTIGATOR

Lymphatic Solutions, Owner

Locations

Lymphatic Solutions, LLC

Houston, Texas, United States

Countries

United States

Other Identifiers

AF22-04-01

Identifier Type: -

Identifier Source: org_study_id