Skip to main content
OpenTrials
Completed

NCT Number: NCT04908254

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema of Upper Arm Lymphedema, Breast Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PT works, Los Altos, California, United States

Loading trial locations.

About this study

A Multi-center Randomized Control Single 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. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Arm Volume Maintenance or Improvement

    Time frame: 1 month

    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

  2. LYMQOL (LYMphedema Quality of Life)

    Time frame: 1 month

    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

Secondary outcomes

  1. Safety/AEs

    Time frame: 1 month

    As assessed by reported adverse events

  2. Therapy adherence tracking

    Time frame: 1 month

    A table will be provided to patient to document days of use with the device to track adherence

  3. Patient survey on preference

    Time frame: 1 month

    A study survey administered at the end of the study to measure patient preference between the two devices

Sponsors and collaborators

Lead sponsor

Koya Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: NILE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2021
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.