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Could a gentle suction device ease lymphedema?

NCT ID NCT03760744

Disease control Sponsor: Vanderbilt University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether adding a device that applies gentle suction (negative pressure) to standard lymphedema therapy helps reduce arm swelling in women who developed lymphedema after cancer treatment. Eighteen participants received both standard therapy and the combined approach in a crossover design. The goal was to see if the combination improved fluid removal and quality of life more than standard care alone.

What this could mean

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

Active substance
Complete decongestive therapy with or without negative pressure (LymphaTouch)
What this could lead to
If successful, this approach could offer a more effective way to manage lymphedema after cancer treatment, reducing swelling and improving daily function.
What could go wrong
This is a small, early-stage study with only 18 participants, so results may not apply to everyone. The added benefit of negative pressure over standard therapy alone is uncertain.

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

18 people

The number who actually took part.

Started

Jan 2019

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

30 to 90 years

Sex

Female participants only

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: * Females with a diagnosis of secondary arm and/or upper quadrant lymphedema following cancer treatments Exclusion Criteria: * Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI * Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced. * Subjects who may have shrapnel embedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes). * Pregnant women will be excluded from the MRI portion of the study only * Subjects who have open wounds on either ankle or top of foot because of contraindications with placement of electrodes to obtain the L-DEX U400 readings. * Persons with heart pacemakers. * Persons with bilateral arm lymphedema (or bilateral risk) or pre-existing lymphedema/edema in the upper body prior to cancer treatments.

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Conditions

The condition(s) this trial relates to.

lymphedema

As listed by the trial registrant

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

Secondary lymphedema

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

More trials for these conditions

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