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NCT06407791 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
A NA study, sponsored by Carilion Clinic.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT06407791 is a NA study that has completed, run by Carilion Clinic. The registered enrollment target is 15 participants.
The verdict
NCT06407791, a NA study, has completed, sponsored by Carilion Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DEVICE LymphaVibe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2025-09-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06407791
The ClinicalTrials.gov registry entry for NCT06407791 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carilion Clinic, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LymphaVibe is the first listed.
NCT06407791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06407791 about?
NCT06407791 is a clinical study titled "Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity". 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...
What is the current status of trial NCT06407791?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2024-05-01. Estimated completion is 2025-09-23.
What interventions are being tested in trial NCT06407791?
The interventions under investigation include: LymphaVibe (DEVICE).
Who is sponsoring clinical trial NCT06407791?
This trial is sponsored by Carilion Clinic, which has 45 total clinical trials registered on ClinicalTrials.gov.
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