ClinicalTrials.gg
RecruitingNCT04888975TIGRISUpdated May 20, 2021

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

An interventional study of Dayspring Active Wearable Compression System in Lymphedema, Lymphedema, Breast Cancer and Lymphedema Arm, sponsored by Koya Medical, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.

Sponsored by Koya Medical, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2021, 4 years 9 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Lymphedema
  • Lymphedema, Breast Cancer
  • Lymphedema Arm
03

In context

Lymphedema

569 studies on the registry are indexed under Lymphedema; 136 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 407 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Koya Medical, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

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

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

    Device: Dayspring Active Wearable Compression System

Interventions

  • DeviceDayspring Active Wearable Compression System

    Dayspring Active Wearable Compression System

06

What researchers measure

Primary outcomes

  1. ICG Fluorescence Lymphatic Imaging

    ICG fluorescence lymphatic imaging evaluates for changes in lymphatic drainage of the limb. ICG is a water soluble tricarbocyanine dye, has a short plasma half life of 3 to 5 minutes in humans, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. ICG contains sodium iodide and is recommended by manufacturer to be used with caution in patients who have a history of allergy to iodides, although type-I allergic reaction (anaphylaxis) cannot really occur because iodine is a chemical element that is an essential component of the human body.

    Time frame: Baseline and at Day 28

07

Study locations

1 of 1 sites recruiting
  • Dung Nguyen, MD, PharmD
    Palo Alto, California 94304, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04888975
Lead sponsor
Koya Medical, Inc.
Responsible party
Sponsor
First posted
May 17, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
May 20, 2021

Study contacts

Dung Nguyen, MD, PharmD
Contact
info@koyamedical.com
4158510337

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion