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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
Carilion Clinic
RECRUITING
Roanoke
Contact Information
Primary
Andre Muelenaer, MD
andrem1@vt.edu
5405209091
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 15
Treatments
Experimental: LymphaVibe Experimental Arm
All patients in this single arm (only arm of the study) will receive both treatment with the LymphaVibe AND the standard of care, thus serving as their own control. Patients will have baseline measurements taken, receive treatment with the LymphaVibe, have their measurements repeated, receive the standard of care, and have their measurements repeated again.
Related Therapeutic Areas
Sponsors
Collaborators: Virginia Polytechnic Institute and State University
Leads: Carilion Clinic

This content was sourced from clinicaltrials.gov