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New wearable device eases arm swelling in breast cancer survivors

NCT ID NCT04908254

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compared a new wearable compression device (Dayspring) to a standard pneumatic pump for treating arm swelling caused by breast cancer treatment. Fifty adults with lymphedema used both devices in a crossover design. Researchers measured arm volume changes and quality of life over one month to see if the wearable device was safer and more effective.

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

50 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2021

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 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

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Conditions

The condition(s) this trial relates to.

Breast Cancer Lymphedema lymphedema

As listed by the trial registrant

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

Lymphedema Lymphedema of upper arm Lymphedema, breast cancer

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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