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

NCT05485454 | Completed FDA Device

• 1 other identifier: AF22-04-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pneumatic Compression Device

Outcome Measures

Primary Outcomes (1)

• Satisfaction and Preference

  The primary outcome of this study is to compare levels of subjective ratings of satisfaction and preference measurements after completed sessions with Aria Free and the traditional PCD devices. Each session is 30 minutes in duration. Subjective measures for each device will use an 11-point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.

  Satisfaction and Preference ratings will be assessed during the only study visit: Visit 1/Day 1.

Secondary Outcomes (2)

• Limb Volume Measurements

  Limb volume measurements will be collected during the only study visit: Visit 1/Day 1.

• Clinician's Skin and Tissue Health Assessment

  The skin and tissue will be assessed during the only study visit: Visit 1/Day 1.

Study Arms (2)

Aria Health Aria Free

ACTIVE COMPARATOR

An Aria Free therapy session on the study lower limb.

Device: Aria Health Aria Free

Traditional PCD

ACTIVE COMPARATOR

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

Device: A Traditional PCD

Interventions

Aria Health Aria Free DEVICE

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

Aria Health Aria Free

A Traditional PCD DEVICE

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

Traditional PCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• ResMed: lead
• Lymphatic Solutions, LLC: collaborator

Study Sites (1)

Lymphatic Solutions, LLC

Houston, Texas, 77058, United States

Location

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise M Baylor, CLT-LANA

  Lymphatic Solutions, Owner

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: August 3, 2022
• Study Start: June 11, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)