Compact Pneumatic Compression Device for Patients With Lymphedema
NCT ID: NCT04226287
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2020-06-16
2020-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Monterey Pneumatic Compression Device
All participants will receive treatment with the Monterey investigational pneumatic compression device
Monterey 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.
Interventions
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Monterey 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.
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of lower limb Lymphedema.
* Able to provide written and informed consent.
* Patient can read and comprehend English.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Locations
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Progressive Physical Therapy and Rehab
Garden Grove, California, United States
Countries
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Other Identifiers
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A0015
Identifier Type: -
Identifier Source: org_study_id
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