18 and older, any sex, with Lymphedema or Lymphedema Lower Extremity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
LYMQOL (LYMphedema Quality of Life) ***All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).***Primary· 3 months
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.
Group
Value
95% CI
Subjects With Lower Extremity Lymphedema and Phlebolymphedema
.83
± .02
Change in Edema VolumePrimary· 3 months
Change in edema volume is measured as the difference between the edema volume at 3 months and edema volume at baseline. Edema volume is the difference in volume between the affected and unaffected limb. Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle and at 4cm increments to the waist region. Measurements are taken for both lower extremities. Volume is calculated based on cylindrical segment analysis.
A greater change in edema volume between the two time points is better on reduction of limb volume/swelling.
Group
Value
95% CI
Subjects With Lower Extremity Lymphedema and Phlebolymphedema
427.1
± 56
Safety/AEsSecondary· 3 months
As assessed by reported adverse events
Group
Value
95% CI
Subjects With Lower Extremity Lymphedema and Phlebolymphedema
0
Number of Patients Using the Device Every Day for at Least 45 MinutesSecondary· 3 months
Outcome measure will be evaluated based on number of patients that have used the device for the recommended use of 45 minutes per day over the duration of 3 months.
Group
Value
95% CI
Subjects With Lower Extremity Lymphedema and Phlebolymphedema
24
Sponsor's own description
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other trials of Dayspring Active Wearable Compression System
Trials testing the same drug.
NCT04888975 — A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients Wit
· NA
· recruiting
Other recruiting trials for Lymphedema
Currently open trials in the same condition.
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· recruiting
NCT07448467 — Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.
· NA
· recruiting
NCT02285868 — ATI Evidence-based Guide Investigating Clinical Services
· active not recruiting
NCT07414615 — Aerobic Training in Lower Extremity Lymphedema
· NA
· recruiting
NCT06866197 — CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System
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Other Koya Medical, Inc. trials
Trials by the same sponsor.
NCT06418282 — Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression D
· NA
· recruiting
NCT05628688 — A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lympha
· completed
NCT05507346 — A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanc
· NA
· completed
NCT04908254 — A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wear
· NA
· completed
NCT04888975 — A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients Wit
· NA
· recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Koya Medical, Inc.
Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04897035.