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

NCT04908254 | Completed FDA Device

• 1 other identifier: KCT003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)

Conditions

Lymphedema; Lymphedema of Upper Arm; Lymphedema, Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Arm Volume Maintenance or Improvement

  Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the wrist and the ulnar styloid process and at 4cm increments to the axilla. Measurements to be taken for both upper extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 1

  1 month

• LYMQOL (LYMphedema Quality of Life)

  The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 1. 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 1

  1 month

Secondary Outcomes (3)

• Safety/AEs

  1 month

• Therapy adherence tracking

  1 month

• Patient survey on preference

  1 month

Study Arms (2)

Dayspring Active Wearable Compression Device

EXPERIMENTAL

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.

Device: Crossover Device (PCD or Dayspring - alternate to first group)

Advanced Pneumatic Compression Device

ACTIVE COMPARATOR

A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.

Device: Crossover Device (PCD or Dayspring - alternate to first group)

Interventions

Crossover Device (PCD or Dayspring - alternate to first group) DEVICE

Cross over arms after a month of use and a month of washout period

Advanced Pneumatic Compression Device; Dayspring Active Wearable Compression Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koya Medical, Inc.: lead

Study Sites (2)

PT works

Los Altos, California, 94024, United States

Location

Ginger-K Lymphedema & Cancer Center

Morgan Hill, California, 95037, United States

Location

Related Publications (2)

• Rockson 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 DERIVED

• Rockson 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 DERIVED

MeSH Terms

Conditions

Lymphedema; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Crossover

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 1, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 9, 2025

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)