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: Completed NA study, sponsored by Koya Medical.
NCT04659564 is a NA study that has completed, run by Koya Medical. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.
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 |
What the finished NCT04659564 record still lists
NCT04659564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which User of Dayspring device is the first listed.
NCT04659564 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04659564's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI