Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04659564 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
A NA study, sponsored by Koya Medical.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT04659564 is a NA study that has completed, run by Koya Medical. The registered enrollment target is 40 participants.
The verdict
NCT04659564, a NA study, has completed, sponsored by Koya Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. The following endpoints are examined: 1. Improvement in QoL in subject with upper-extremity edema after 28 days as measured by the LYMQOL disease-specific validated assessment tool. 2. Arm volume maintenance or improvement as measured prior to and after 28 days of device use. 3. Safety as assessed by reported adverse events 4. Patient satisfaction as measured by visual analog scale (VAS) and survey at the end of the study; and 5. Adherence to therapy as measured with a smart phone app.
Interventions
- DEVICE User of Dayspring device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-08-05 |
| Est. Completion | 2021-05-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04659564
The ClinicalTrials.gov registry entry for NCT04659564 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Koya Medical, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which User of Dayspring device is the first listed.
NCT04659564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04659564 about?
NCT04659564 is a clinical study titled "Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study". An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use seq...
What is the current status of trial NCT04659564?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2020-08-05. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT04659564?
The interventions under investigation include: User of Dayspring device (DEVICE).
Who is sponsoring clinical trial NCT04659564?
This trial is sponsored by Koya Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.