Compact Pneumatic Compression Device for Patients With Lymphedema

NCT04226287 | Completed

• 1 other identifier: A0015
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema of Limb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of Therapy provided by Monterey Investigational system

  1 week

Study Arms (1)

Monterey Pneumatic Compression Device

EXPERIMENTAL

All participants will receive treatment with the Monterey investigational pneumatic compression device

Device: Monterey Pneumatic Compression Device

Interventions

Monterey Pneumatic Compression Device 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.

Monterey Pneumatic Compression Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Progressive Physical Therapy and Rehab

Garden Grove, California, 92843, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: June 16, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)