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

NCT06407791 | Completed DMC FDA Device

• 1 other identifier: IRB-22-1780
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Rates of reported side effects

  Will be assessed by recording rates of side effects reported by study subjects

  Weekly for 4 weeks

• Device efficacy in reducing lymphedema burden

  Will be assessed by recording changes in upper extremity circumference (cm)

  Weekly for 4 weeks

• Device efficacy in reducing lymphedema burden

  Will be assessed by recording changes in upper extremity induration

  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

  Weekly for 4 weeks

Study Arms (1)

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.

Device: LymphaVibe

Interventions

LymphaVibe DEVICE

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

LymphaVibe Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Related Publications (1)

• 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/

  PMID: 30725924 BACKGROUND

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ralph Brown, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: May 9, 2024
• Study Start: May 1, 2024
• Primary Completion: January 9, 2025
• Study Completion: September 23, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)