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

NCT05485454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-09-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Lymphatic Solutions, LLC

    collaborator UNKNOWN

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Denise M Baylor, CLT-LANA · Lymphatic Solutions, Owner

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-11
Primary Completion
2022-07-30
Completion
2022-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485454 on ClinicalTrials.gov