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Device

LymphaVibe for Upper Extremity Lymphedema

N/A
Waitlist Available
Led By Ralph Brown, MD
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Clinical diagnosis of lymphedema
Must not have
Active phlebitis
Active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly for 4 weeks
Awards & highlights

Summary

This trial aims to test a new device for treating lymphedema in the arms. The device has been found safe in healthy individuals and is now being tested on patients with diagnosed lymphedema. Participants

Who is the study for?
This trial is for individuals with upper extremity lymphedema. Participants will be those already diagnosed and receiving care for their condition, willing to use the LymphaVibe device as part of their treatment.
What is being tested?
The study tests the safety and effectiveness of the LymphaVibe device in treating arm lymphedema. Patients will use the device once, followed by standard care, while measurements are taken before and after to assess changes in arm size and pain.
What are the potential side effects?
Reported side effects from using LymphaVibe may include discomfort or other reactions similar to those experienced during standard lymphedema treatments; however, it's previously shown no significant impact on vital signs or pain levels in healthy individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with lymphedema.
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I can make my own medical decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have inflammation in my veins.
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I currently have an infection.
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I have had a deep vein thrombosis or pulmonary embolism in the past.
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I have had vascular surgery in the past.
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I have been diagnosed with congestive heart failure.
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I have open sores or weeping lesions in the area to be treated.
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My cancer is currently active and not in remission.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device efficacy in reducing lymphedema burden
Rates of reported side effects

Trial Design

1Treatment groups
Experimental Treatment
Group I: LymphaVibe Experimental ArmExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor
76 Previous Clinical Trials
14,827 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityOTHER
149 Previous Clinical Trials
30,473 Total Patients Enrolled
Ralph Brown, MDPrincipal InvestigatorCarilion Clinic
~9 spots leftby May 2025
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