Compact Pneumatic Compression Device for Patients With Lymphedema

ResMed12 enrolled

Overview

This is a pilot study for usability and efficacy, and as such it is designed for 15 participants. The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting. The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting over one week of daily use. Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lymphedema of Limb

Interventions

Monterey Pneumatic Compression DeviceDEVICE

The MontereyInvestigational System is a compact pneumatic compression device used for the treatment of either primary or secondary lymphedema. The primary intention in this study is to gather usability design feedback. This will be done by observing how a patient uses the device after a brief demonstration from the clinician. Errors and difficulties will be noted by the ResMed representative observing the trial. The qualitative interview with the patient at the end of the trial will yield additional understanding of the patient experience with the device.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel. * A diagnosis of lower limb Lymphedema. * Able to provide written and informed consent. * Patient can read and comprehend English. 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

Locations (1)

Progressive Physical Therapy and Rehab

Garden Grove, California, United States

Outcomes

Primary Outcomes

Usability of the Monterey Investigational System in a monitored clinic environment

Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.

Time frame: 1 week

Secondary Outcomes

Efficacy of Therapy provided by Monterey Investigational system

Efficacy will be determined by comparing lower limb volume measured prior to commencing therapy and at the conclusion. The truncated cone formula is a well-established measure used for assessing limb volume \[1\]. The limb is divided into segments as per figure 2, measurements taken and volume in each segment is calculated as per the following formula: Voln = L/12(pi)(C1\^2+C2\^2+C1\*C2)

Time frame: 1 week

Data from ClinicalTrials.gov

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