Compact Pneumatic Compression Device for Patients With Lymphedema

Pilot Study of a Compact Pneumatic Compression Device for Patients With Lymphedema

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema of Limb
• Intervention / Treatment: Device: Monterey Pneumatic Compression Device

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92843
      • Progressive Physical Therapy and Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Monterey Pneumatic Compression Device; All participants will receive treatment with the Monterey investigational pneumatic compression device

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 week

Collaborators and Investigators

• Sponsor: ResMed

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: A0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No