Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity

Completed · Not applicable

Conditions studied: Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm

In brief

Lymphedema is a painful and disfiguring condition related to the buildup of protein-rich fluid in the body's tissues. The goal of this research study is to determine the safety and efficacy of a novel, proprietary device in the treatment of upper extremity lymphedema. This device has been previously studied on healthy people that do not have a diagnosis of lymphedema. It was found that using the device on them does not cause significant changes to their vital signs or level of pain. Side effects are reported sometimes; however, these are to be expected and are also frequently reported when people receive the standard of care for their lymphedema. Patients who have diagnosed lymphedema will be approached to participate in this study as part of their care. Participants will wear this device for approximately 40 minutes and then have certain measurements taken before and after doing so. These measurements include the size of their arm, how much pain/discomfort they are currently in, and if they experienced any side effects. After getting treatment with the device, they will receive the standard of care treatment for their lymphedema from their provider. After the standard of care has concluded, the previously mentioned measurements will be repeated. This data will be put together and analyzed to look for differences in arm size before and after treatment with the device as well as to look for the prevalence of side effects.

Key facts

Study ID

NCT06407791

Run by

Carilion Clinic

People needed

15

Starts

2024-05-01

Expected to finish

2025-09-23

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Clinical diagnosis of lymphedema
• Receiving current, once weekly, lymphedema treatment by Physical Therapist(PT)/Occupational Therapist (OT)
• Participants must have the ability to provide consent for themselves

You may not qualify if…

• Active infection
• Active cancer (not in remission)
• Diagnosis of/past medical history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
• Active phlebitis
• Diagnosis of Congestive Heart Failure (CHF)
• Previous severe trauma (i.e. requiring extensive corrective surgery)
• History of vascular surgery
• Lesions of the skin or weeping in the treatment area

Where it is running

• Carilion Clinic — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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