Evaluation of a device for treating upper arm lymphedema
Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
This study is testing a new device that uses vibration and a special sleeve to see if it can help people with lymphedema in their arms feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carilion Clinic Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT06407791 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on assessing the safety and efficacy of a novel device designed to treat lymphedema in the upper extremity. Participants diagnosed with lymphedema will wear an 'athletic sleeve' fitted by the research team, followed by the application of a vibratory therapy device. Measurements of arm circumference and discomfort levels will be taken before and after using the device to evaluate its impact. The study aims to enhance current treatment options for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of lymphedema who are currently receiving weekly treatment from a physical or occupational therapist.
Not a fit: Patients with active infections, cancer not in remission, or a history of deep vein thrombosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a new, effective treatment option for patients suffering from upper extremity lymphedema.
How similar studies have performed: While this approach is novel, previous studies have shown promise in using similar devices for therapeutic purposes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roanoke, Virginia
- Carilion Clinic — Roanoke, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Ralph Brown, MD — Carilion Clinic
- Study coordinator: Andre Muelenaer, MD
- Email: andrem1@vt.edu
- Phone: 5405209091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.