Compact Pneumatic Compression Device for Patients With Lymphedema

Pilot Study of a Compact Pneumatic Compression Device for Patients With Lymphedema

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.

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