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

January 20, 2026 updated by: Carilion Clinic
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For each study visit, participants will be asked to arrive 45 minutes before the beginning of their regularly scheduled follow-up visit. Research activities will take 45 minutes.

Upon early arrival to their regularly scheduled appointment, participants will be fitted for their very own, "athletic sleeve" by a member of the research team. This athletic sleeve will be used throughout the duration of the study. Participants will be asked to come wearing a tank top or short-sleeved t-shirt. If they do not come dressed as such, they will have the opportunity to change in a private space.

Before donning the athletic sleeve, a member of the research team will measure the participant's upper limb circumference and induration and administer a baseline survey using the first section of the Lymphedema Life Impact Scale (LLIS - document attached). Upper extremity circumference will be measured in centimeters at several points, which are: palmar crease, the wrist below the styloid process, wrist + 10 cm, wrist + 20 cm, wrist + 30 cm, and wrist + 40 cm. Upper extremity induration will be measured at the same points as circumference. These measurements are being taken solely for research purposes and should take approximately 3 minutes.

The athletic sleeve will be donned by the participant and the novel therapeutic device will be placed over it. A standardized sequence of vibratory therapy will be applied. Use of this device will not impact standard of care in any way. The participant may ask to stop the research session at any time

The athletic sleeve will then be removed, and a member of the research team will measure the participant's upper limb circumference and induration and administer a survey using the first section of the Lymphedema Life Impact Scale. These measurements are being taken solely for research purposes and should take approximately 3 minutes. Participants will be asked if they experienced any side effects or adverse effects.

Standardized decongestive therapy will be performed by qualified personnel. This step takes approximately 1 hour and would happen regardless or whether or not patients are enrolled in this study. At the conclusion of the standardized decongestive therapy, the measurements and surveys mentioned previously will be repeated. Participants will also be asked if they experienced any side effects with the standard of care treatment.

This series of steps will be repeated at the participants' weekly follow-up visits for four weeks. Standardized decongestive therapy for lymphedema is most often performed on a weekly basis (and is one of the inclusion criteria for this study). Therefore, choosing this visit frequency would not greatly alter a participant's schedule or ability to perform other daily tasks.

If a participant chooses to withdraw from the study early or needs to be removed from the study for their own safety, notes will be added to research documentation and the patient's electronic medical chart indicating their departure from the study. Going forward, they would receive standard decongestive therapy as before their participation in the study.

Study subject limb circumference, induration data, and survey data will be analyzed using a paired t-test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Andre Muelenaer, MD
  • Phone Number: 5405209091
  • Email: andrem1@vt.edu

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of reported side effects
Time Frame: Weekly for 4 weeks
Will be assessed by recording rates of side effects reported by study subjects
Weekly for 4 weeks
Device efficacy in reducing lymphedema burden
Time Frame: Weekly for 4 weeks
Will be assessed by recording changes in upper extremity circumference (cm)
Weekly for 4 weeks
Device efficacy in reducing lymphedema burden
Time Frame: Weekly for 4 weeks
Will be assessed by recording changes in upper extremity induration
Weekly for 4 weeks
Device efficacy in reducing lymphedema burden
Time Frame: Weekly for 4 weeks
Will be assessed by recording changes in the first section of the Lymphedema Life Impact Scale (LLIS) score that deals with physical symptoms of lymphedema only
Weekly for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carilion Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Virginia Polytechnic Institute and State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ralph Brown, MD, Carilion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-22-1780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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