NCT04226287

Compact Pneumatic Compression Device for Patients With Lymphedema

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-16
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2020-01-13
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States