COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-01
Study Completion:2025-09-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06407791

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Clinical diagnosis of lymphedema
  3. * Receiving current, once weekly, lymphedema treatment by Physical Therapist(PT)/Occupational Therapist (OT)
  4. * Participants must have the ability to provide consent for themselves
  1. * Active infection
  2. * Active cancer (not in remission)
  3. * Diagnosis of/past medical history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
  4. * Active phlebitis
  5. * Diagnosis of Congestive Heart Failure (CHF)
  6. * Previous severe trauma (i.e. requiring extensive corrective surgery)
  7. * History of vascular surgery
  8. * Lesions of the skin or weeping in the treatment area

Contacts and Locations

Principal Investigator

Ralph Brown, MD
PRINCIPAL_INVESTIGATOR
Carilion Clinic

Study Locations (Sites)

Carilion Clinic
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Carilion Clinic

  • Ralph Brown, MD, PRINCIPAL_INVESTIGATOR, Carilion Clinic

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 Registration Dates

Study Start Date2024-05-01
Study Completion Date2025-09-23

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2025-09-23

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphedema
  • Lymphedema Arm
  • Lymphedema of Upper Arm