Recruiting

Dayspring Technology

Sponsor:

Koya Medical, Inc.

Code:

NCT04888975

Conditions

Lymphedema

Lymphedema, Breast Cancer

Lymphedema Arm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dayspring Active Wearable Compression System

Study Details

Brief summary:

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

Conditions

Lymphedema

Lymphedema, Breast Cancer

Lymphedema Arm

Study ID

NCT04888975

Start date

Jun 1, 2021

Status verified date

May, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen
  • Subjects must have a difference in volume greater than 3% between the limbs.

Exclusion Criteria:

  • Individuals with a history or presence of a systemic disorder or condition that could place the patient 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
  • Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
  • Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
  • Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
  • Diagnosis of lipedema
  • Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior 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 during the past 30 days
  • Bilateral limb edema

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery

Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery

Interventions

Dayspring Active Wearable Compression System

Dayspring Active Wearable Compression System

Primary outcome measure

  • ICG Fluorescence Lymphatic Imaging [ Time Frame: Baseline and at Day 28 ]

Central Contacts and Locations

Central contacts

Dung Nguyen, MD, PharmD

4158510337info@koyamedical.com

Locations

Dung Nguyen, MD, PharmD

Recruiting

Palo Alto, California, United States, 94304

Contacts

Dung Nguyen, MD, PharmD

415-851-0337info@koyamedical.com

More Information

Sponsor

Koya Medical, Inc.

Last update posted

May 20, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Koya Medical, Inc. on 2021-05-20.