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OpenTrials
Completed

NCT Number: NCT04226287

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.

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Key information

Conditions

Lymphedema of Limb

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Progressive Physical Therapy and Rehab

Garden Grove, California, 92843, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Usability of the Monterey Investigational System in a monitored clinic environment

    Time frame: 1 week

    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 outcomes

  1. Efficacy of Therapy provided by Monterey Investigational system

    Time frame: 1 week

    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)

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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