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NCT04897035 · ClinicalTrials.gov registry record · NA
Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema
A NA study, sponsored by Koya Medical.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT04897035: Completed NA study, sponsored by Koya Medical.
NCT04897035 is a NA study that has completed, run by Koya Medical. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04897035, a NA study, has completed, sponsored by Koya Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Primary Outcome
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 3. Higher value is better on the QoL outcome and is more favorable.
Interventions
- DEVICE Dayspring Active Wearable Compression System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2022-07-01 |
| Phase | NA |
What the finished NCT04897035 record still lists
NCT04897035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Dayspring Active Wearable Compression System is the first listed.
NCT04897035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04897035 about?
NCT04897035 is a clinical study titled "Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema". A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
What is the current status of trial NCT04897035?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2021-06-01. Estimated completion is 2022-07-01.
What interventions are being tested in trial NCT04897035?
The interventions under investigation include: Dayspring Active Wearable Compression System (DEVICE).
Who is sponsoring clinical trial NCT04897035?
This trial is sponsored by Koya Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04897035's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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