Compact Pneumatic Compression Device for Patients With Lymphedema

Lymphedema of Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226287
• Other study ID #: A0015
• Status: Completed
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Limb

Intervention

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.

Locations

Country	Name	City	State
United States	Progressive Physical Therapy and Rehab	Garden Grove	California

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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