LymphedemaNCT06407791
Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
A study testing LymphaVibe in people with Lymphedema and Lymphedema Arm, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm
- What is being tested?
- LymphaVibe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 23 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm
- Being tested
- LymphaVibe
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphaVibeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| LymphaVibe Experimental Arm | Experimental | 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. Receives: Device: LymphaVibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of reported side effects
Will be assessed by recording rates of side effects reported by study subjects
Measured: Weekly for 4 weeks
Device efficacy in reducing lymphedema burden
Will be assessed by recording changes in upper extremity circumference (cm)
Measured: Weekly for 4 weeks
Device efficacy in reducing lymphedema burden
Will be assessed by recording changes in upper extremity induration
Measured: Weekly for 4 weeks
Device efficacy in reducing lymphedema burden
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
Measured: Weekly for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 May 2024
- Primary completion9 Jan 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Sponsor
- Investigators
- Ralph Brown, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407791
- Sponsor's protocol ID
- IRB-22-1780
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nimmana BK, Kimyaghalam A, Manna B. Lymphedema. 2025 Oct 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537239/
PubMed 30725924
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
- ClinicalTrials.gov ID
- NCT06407791
- Acronym / sponsor ID
- IRB-22-1780
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LymphaVibe Experimental Arm | Experimental | Device: LymphaVibeAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LymphaVibeThe 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 | Device | LymphaVibe Experimental Arm |
Primary outcome
Rates of reported side effects
Time frame: Weekly for 4 weeks
Will be assessed by recording rates of side effects reported by study subjects
Device efficacy in reducing lymphedema burden
Time frame: Weekly for 4 weeks
Will be assessed by recording changes in upper extremity circumference (cm)
Device efficacy in reducing lymphedema burden
Time frame: Weekly for 4 weeks
Will be assessed by recording changes in upper extremity induration
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 30725924Nimmana BK, Kimyaghalam A, Manna B. Lymphedema. 2025 Oct 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537239/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Brown, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LymphaVibe in people with Lymphedema and Lymphedema Arm, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of reported side effects (time frame: Weekly for 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.