Last reviewed · How we verify
NCT04908254: NILE
A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema
NA trial testing Crossover Device (PCD or Dayspring - alternate to first group) in Lymphedema in 50 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | Koya Medical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 June 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Crossover Device (PCD or Dayspring - alternate to first group)
Conditions studied
- Lymphedema — all drugs for Lymphedema →
- Lymphedema of Upper Arm — all drugs for Lymphedema of Upper Arm →
- Lymphedema, Breast Cancer — all drugs for Lymphedema, Breast Cancer →
Sponsor
Koya Medical, Inc. — full company profile →
Who can join
18 and older, any sex, with Lymphedema or Lymphedema of Upper Arm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effectiveness of a Nonpneumatic Active Compression Device in Older Adults with Breast Cancer-Related Lymphedema: A Subanalysis of a Randomized Crossover Trial.
Rockson SG, Skoracki R. · · 2023 · cited 1× · PMID 37729078 · DOI 10.1089/lrb.2022.0085
Verify or expand the search:
- PubMed search for NCT04908254
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lymphedema
Currently open trials in the same condition.
- NCT07489248 — Multimodal Ultrasound for Differentiating Lymphedema and Lipedema · 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 · NA · recruiting
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
- NCT04897035 — Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema · NA · completed
- NCT04888975 — A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients Wit · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04908254 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 9 December 2025
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/NCT04908254.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing