Back to resultsCompact Pneumatic Compression Device for Patients With Lymphedema
Primary Purpose
Lymphedema of Limb
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monterey Pneumatic Compression Device
Sponsored by
About this trial
This is an interventional other trial for Lymphedema of Limb
Eligibility Criteria
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
Sites / Locations
- Progressive Physical Therapy and Rehab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monterey Pneumatic Compression Device
Arm Description
All participants will receive treatment with the Monterey investigational pneumatic compression device
Outcomes
Primary Outcome Measures
Usability of the Monterey Investigational System in a monitored clinic environment
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 Outcome Measures
Efficacy of Therapy provided by Monterey Investigational system
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04226287
Brief Title
Compact Pneumatic Compression Device for Patients With Lymphedema
Official Title
Pilot Study of a Compact Pneumatic Compression Device for Patients With Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Limb
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monterey Pneumatic Compression Device
Arm Type
Experimental
Arm Description
All participants will receive treatment with the Monterey investigational pneumatic compression device
Intervention Type
Device
Intervention Name(s)
Monterey Pneumatic Compression Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usability of the Monterey Investigational System in a monitored clinic environment
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Efficacy of Therapy provided by Monterey Investigational system
Description
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)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Progressive Physical Therapy and Rehab
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compact Pneumatic Compression Device for Patients With Lymphedema
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