Lymphedema of Limb
Conditions
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.
Interventions
DEVICEMonterey Pneumatic Compression Device
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.
Sponsors
ResMed
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed