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New device aims to spot swelling and vein problems safely

NCT ID NCT05628688

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called Insight Pro to see if it can safely detect lymphatic and vein disorders, such as lymphedema and chronic venous insufficiency. The device measures fluid buildup and skin hardness in the arms or legs. A total of 67 adults with or without these conditions took part. The goal was to check if the device works well and is safe to use.

What this could mean

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

Active substance
Insight Pro Device
What this could lead to
If successful, this device could offer a safe, non-invasive way to diagnose lymphatic and venous disorders, potentially replacing more invasive tests.
What could go wrong
This is a small, completed study focused on safety and detection ability. The device may not be more accurate than existing methods, and results may not apply to all patients.

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.

Participants

67 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2025

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.

Who is studied

(Test Group) - Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity. (Control Group) Up to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Test group - * Males and females ≥ 18 years of age * Willing to sign the informed consent and deemed capable of following the study protocol * Subjects must have primary or secondary unilateral or bilateral upper or 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 Control group - * Males and females ≥ 18 years of age * Willing to sign the informed consent and deemed capable of following the study protocol * Subjects must not have primary or secondary edema and self-describe general healthy Exclusion Criteria: * ● Inability or unwillingness to participate in all aspects of the study protocol and/or failure 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 (\< 3 months since completion of chemotherapy, radiation therapy, or primary surgery for the cancer) * Patients with cardiac arrhythmia with pacemakers or other implanted electronic equipment * Patients must not have implanted metal hardware in the limbs * Patients undergoing external defibrillation * Diagnosis of Acute infection (in the last four weeks) * Diagnosis of acute thrombophlebitis (in last 2 months) * Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 2 months * Diagnosis of congestive heart failure (uncontrolled) * Diagnosis of chronic kidney disease with acute renal failure * 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 Edema lymphedema venous insufficiency

As listed by the trial registrant

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

Chronic venous insufficiency Edema Lymphedema Venous insufficiency of leg

Contacts and locations

Locations

  • Koya Medical, Inc.

    Oakland, California, 94607, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.