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

NCT06407791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Lymphedema
  • Lymphedema Arm
  • Lymphedema of Upper Arm

Interventions

DEVICE

LymphaVibe

The LymphaVibe is a newly-developed device that uses a vibratory sequence to gently move stagnant lymphatic fluid from the arm to the nearest group of functioning lymph nodes

Sponsors & Collaborators

  • Virginia Polytechnic Institute and State University

    collaborator OTHER

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Ralph Brown, MD · Carilion Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-01-09
Completion
2025-09-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06407791 on ClinicalTrials.gov