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New wearable device aims to ease lymphedema swelling

NCT ID NCT04897035

Symptom relief Sponsor: Koya Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a wearable compression device called Dayspring for people with lymphedema in one leg. 24 adults used the device daily for 3 months. Researchers measured changes in leg swelling and quality of life to see if the device was safe and helpful.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dayspring Active Wearable Compression System (a wearable compression device)
What this could lead to
If it works, this could offer a more convenient, active way to manage lymphedema swelling and improve quality of life without traditional bandages.
What could go wrong
This was a small, non-randomized study with only 24 people, so results may not apply to everyone. The device requires daily use, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

24 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 lower extremity edema * At the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable Exclusion Criteria: * Individuals with a history or presence of an acute 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.) * Patients 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 acute renal failure * Diagnosis of epilepsy * Patients 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

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency lymphatic malformation 5 lymphedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic venous insufficiency Lymphedema Lymphedema lower extremity Secondary lymphedema

Contacts and locations

Locations

  • Ginger-K Lymphedema & Cancer Center

    Morgan Hill, California, 95037, United States

  • PT works

    Los Altos, California, 94024, United States

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