A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery

Last updated: May 18, 2021
Sponsor: Koya Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphedema

Treatment

N/A

Clinical Study ID

NCT04888975
KCT 005
  • Ages > 18
  • All Genders

Study Summary

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • Willing to sign the informed consent and deemed capable of following the studyprotocol
  • Subjects must have a diagnosis of upper extremity edema and have or will undergolymphatic surgery with Dr. Nguyen
  • Subjects must have a difference in volume greater than 3% between the limbs.

Exclusion

Exclusion Criteria:

  • Individuals with a history or presence of a systemic disorder or condition that couldplace the patient at increased risk from sequential compression therapy
  • Inability or unwillingness to participate in all aspects of study protocol and/orinability to provide informed consent
  • Patients with exam results that would prevent safe and effective use of the studydevice (cellulitis, open-wounds, healing-wounds, etc.)
  • Diagnosis of active or recurrent cancer, or less than 3 months at the time of initialevaluation from the completion of chemotherapy, radiation therapy or primary surgeryfor the treatment of cancer
  • Patients must not have any diagnosed cognitive or physical impairment that wouldinterfere with use of the device
  • Diagnosis of lipedema
  • Diagnosis of acute infection. The source of the infection must be treated for 2 weeksprior to admittance into the study
  • Diagnosis of acute thrombophlebitis (in last 2 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
  • Diagnosis of epilepsy
  • Patients with poorly controlled asthma
  • Women who are pregnant, planning a pregnancy or nursing at study entry
  • Participation in any clinical trial of an investigational substance or device duringthe past 30 days
  • Bilateral limb edema

Study Design

Total Participants: 20
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2021

Study Description

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Connect with a study center

  • Dung Nguyen, MD, PharmD

    Palo Alto, California 94304
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.