Compact Pneumatic Compression Device for Patients With Lymphedema

Completed · Not applicable

Conditions studied: Lymphedema of Limb

In brief

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.

Key facts

Study ID

NCT04226287

Run by

ResMed

People needed

12

Starts

2020-06-16

Expected to finish

2020-08-31

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

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

Where it is running

• Progressive Physical Therapy and Rehab — Garden Grove, California, United States

Full record on ClinicalTrials.gov

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