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Usability evaluation of a compact pneumatic compression device for patients with lymphoedema

Usability evaluation of the fit, comfort and ease of use of a novel pressure delivery device in adults with Lymphedoema

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000343909
Acronym
UEPCD
Enrollment
15
Registered
2020-03-11
Start date
2019-09-11
Completion date
2020-03-31
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 • Conne

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

ResMed Pty. Ltd.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026