Clinical trial · Interventional
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
A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema
NCT04908254CI-TRIAL-00098698NILEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema, Breast Cancer | — | UNRESOLVED | — |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crossover Device (PCD or Dayspring - alternate to first group) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dayspring Active Wearable Compression Device
- description
- The Dayspring Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure full-arm compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.
- interventionNames
- Device: Crossover Device (PCD or Dayspring - alternate to first group)
- type
- ACTIVE_COMPARATOR
- label
- Advanced Pneumatic Compression Device
- description
- A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.
- interventionNames
- Device: Crossover Device (PCD or Dayspring - alternate to first group)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females ≥ 18 years of age * Willing to sign the informed consent and deemed capable of following the study protocol * Subjects must have a diagnosis of primary or secondary unilateral upper extremity edema Exclusion Criteria: * Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy * Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * Subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device * Diagnosis of lipedema * Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer) * Diagnosis of Acute infection (in the last four weeks) * Diagnosis of acute thrombophlebitis (in last 6 months) * Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * Diagnosis of pulmonary edema * Diagnosis of congestive heart failure (uncontrolled) * Diagnosis of chronic kidney disease with renal failure * Diagnosis of epilepsy * Subjects with poorly controlled asthma * Any condition where increased venous and lymphatic return is undesirable * Women who are pregnant, planning a pregnancy or nursing at study entry * Participation in any clinical trial of an investigational substance or device during the past 30 days
References
Publications (2)
- DERIVEDRockson SG, Skoracki R. Effectiveness of a Nonpneumatic Active Compression Device in Older Adults with Breast Cancer-Related Lymphedema: A Subanalysis of a Randomized Crossover Trial. Lymphat Res Biol. 2023 Dec;21(6):581-584. doi: 10.1089/lrb.2022.0085. Epub 2023 Sep 20. PMID 37729078
- DERIVEDRockson SG, Whitworth PW, Cooper A, Kania S, Karnofel H, Nguyen M, Shadduck K, Gingerich P, Armer J. Safety and effectiveness of a novel nonpneumatic active compression device for treating breast cancer-related lymphedema: A multicenter randomized, crossover trial (NILE). J Vasc Surg Venous Lymphat Disord. 2022 Nov;10(6):1359-1366.e1. doi: 10.1016/j.jvsv.2022.06.016. Epub 2022 Aug 8. PMID 35952956