Compact Pneumatic Compression Device for Patients With Lymphedema
- Conditions
- Lymphedema of Limb
- Interventions
- Device: Monterey Pneumatic Compression Device
- Registration Number
- NCT04226287
- Lead Sponsor
- ResMed
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Monterey Pneumatic Compression Device Monterey Pneumatic Compression Device All participants will receive treatment with the Monterey investigational pneumatic compression device
- Primary Outcome Measures
Name Time Method Usability of the Monterey Investigational System in a monitored clinic environment 1 week 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.
- Secondary Outcome Measures
Name Time Method Efficacy of Therapy provided by Monterey Investigational system 1 week 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)
Trial Locations
- Locations (1)
Progressive Physical Therapy and Rehab
🇺🇸Garden Grove, California, United States