None listed
Conditions
Brief summary
This is a preliminary evaluation of the usability of a compact pneumatic compression device (Monterey) currently under development. The study is focused on evaluating comfort and ease of use in a group of non-naive Lymphedema patients
Interventions
This is a usability study aiming to assess the fit, comfort and ease of use of a novel investigational pressure delivery system (referred to as Monterey), which will be used as the intervention in this study. The Monterey is an investigational system intended for patients with primary or secondary lymphoedema. It consists of the following components: • Pressure generator which delivers a pressure of 35 mmHG • Valve Interface • Patient interface: foot-thigh pneumatic compression garment • Connection tubes (Integrated Tube) The patient-interface is worn by wrapping it around the limb. It is then connected to the pressure generator via the provided tube. The valve interface is integrated into the patient-interface and its purpose is to allow segmented pressure control in the garment. Participants will be asked to visit the ResMed sleep centre, where they will be asked to use and provide feedback on the novel pressure delivery system. The study will involve two visits for participants and each visit will take up to 90mins. Visit 1 will assess the participants ability to connect the device and fit the pneumatic compression garment. Visit 2 will assess comfort when the device therapy is turned on (45 minutes for this study). As this is a usability study, there is no requirement on the frequency of visits. Visits will be scheduled based on participant availability. The entire study will be conducted under the supervision of the principal investigator. Usability and comfort will be assessed qualitatively using questionnaires.
Sponsors
Study design
Eligibility
Inclusion criteria
• Patients who are greater than or equal to 18 years, mentally able to understand and follow the instructions of the study personnel. • A diagnosis of lower limb lymphoedema. • Established user’s pneumatic compression (must have had device for at least one (1) month). • Able to provide written and informed consent.
Exclusion criteria
• Subject undergoing cancer treatment. • Subject has active lower limb wounds. • Subject is pregnant or trying to become pregnant. • History of pulmonary oedema 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.