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Trial registered on ANZCTR


Registration number
ACTRN12620000343909
Ethics application status
Approved
Date submitted
20/02/2019
Date registered
11/03/2020
Date last updated
11/03/2020
Date data sharing statement initially provided
11/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Usability evaluation of a compact pneumatic compression device for patients with lymphoedema
Scientific title
Usability evaluation of the fit, comfort and ease of use of a novel pressure delivery device in adults with Lymphedoema
Secondary ID [1] 297452 0
None
Universal Trial Number (UTN)
U1111-1228-8646
Trial acronym
UEPCD
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Lymphedoema 311639 0
Condition category
Condition code
Cardiovascular 310261 310261 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313710 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319150 0
Visit 1
The primary objective of this phase is to evaluate the subjective fit of the Monterey pneumatic compression garment in a monitored clinic environment. This 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.
Timepoint [1] 319150 0
One off measurement at the end of visit 1
Primary outcome [2] 322179 0
Visit 2
The primary objective of this study is to assess the subjective comfort of the Monterey Investigational System in a monitored clinic environment over 45 (forty-five) minutes of use. This 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.
Timepoint [2] 322179 0
One off measurement at the end of visit 2
Secondary outcome [1] 377599 0
Visit 1
Subjective rating of ease of use. This 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.
Timepoint [1] 377599 0
One off measurement at the end of visit 1
Secondary outcome [2] 380261 0
Visit 1
Subjective rating of comfort. This 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.
Timepoint [2] 380261 0
One off measurement at the end of visit 1
Secondary outcome [3] 380531 0
Visit 2
Subjective rating of ease of use. This 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.
Timepoint [3] 380531 0
One off measurement at the end of visit 2
Secondary outcome [4] 380532 0
Visit 2
Subjective rating of fit. This 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.
Timepoint [4] 380532 0
One off measurement at the end of visit 2

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/09/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302024 0
Commercial sector/Industry
Name [1] 302024 0
ResMed Pty. Ltd.
Country [1] 302024 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Pty. Ltd.
Address
1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2153
Country
Australia
Secondary sponsor category [1] 301818 0
None
Name [1] 301818 0
None
Address [1] 301818 0
None
Country [1] 301818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302701 0
Bellberry
Ethics committee address [1] 302701 0
123 Glen Osmond Rd, Eastwood, SA, 5063
Ethics committee country [1] 302701 0
Australia
Date submitted for ethics approval [1] 302701 0
21/03/2019
Approval date [1] 302701 0
25/07/2019
Ethics approval number [1] 302701 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91106 0
Dr Martin Devitt
Address 91106 0
Lifecycle Medical, PO Box 500, Newport, NSW, 2106.
Country 91106 0
Australia
Phone 91106 0
+61 403226310
Fax 91106 0
Email 91106 0
[email protected]
Contact person for public queries
Name 91107 0
Martin Devitt
Address 91107 0
Lifecycle Medical, PO Box 500, Newport, NSW, 2106.
Country 91107 0
Australia
Phone 91107 0
+61 403226310
Fax 91107 0
Email 91107 0
[email protected]
Contact person for scientific queries
Name 91108 0
Martin Devitt
Address 91108 0
Lifecycle Medical, PO Box 500, Newport, NSW, 2106.
Country 91108 0
Australia
Phone 91108 0
+61 403226310
Fax 91108 0
Email 91108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All patient data will be deidentifed and stored securely. This is a preliminary usability evaluation of a prototype device and data will only be useful for informing further product development activities


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.