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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly for 4 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 10Eligibility criteria met