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NCT05507346 · ClinicalTrials.gov registry record · NA
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
A NA study, sponsored by Koya Medical.
- Completed
- Registry status
- NA
- Development phase
- 121
- Enrollment target
NCT05507346: Completed NA study, sponsored by Koya Medical.
NCT05507346 is a NA study that has completed, run by Koya Medical. The registered enrollment target is 121 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05507346, a NA study, has completed, sponsored by Koya Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 121 participants
- Enrollment target
Study Summary
To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
Primary Outcome
Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle at 4cm increments to the waist region. Measurements to be taken for both lowerr extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 3
Interventions
- DEVICE Cross over Device (PCD or Dayspring - alternate to first group)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2024-01-09 |
| Phase | NA |
What the finished NCT05507346 record still lists
NCT05507346 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Cross over Device (PCD or Dayspring - alternate to first group) is the first listed.
NCT05507346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05507346 about?
NCT05507346 is a clinical study titled "A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema". To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
What is the current status of trial NCT05507346?
This trial is currently completed. It is a NA study. The enrollment target is 121 participants. The study started on 2022-09-06. Estimated completion is 2024-01-09.
What interventions are being tested in trial NCT05507346?
The interventions under investigation include: Cross over Device (PCD or Dayspring - alternate to first group) (DEVICE).
Who is sponsoring clinical trial NCT05507346?
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 NCT05507346's enrollment target sits among peer trials
121 762nd of 2000 higher than 1,239 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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