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Can a smarter sleeve beat lymphedema?

NCT ID NCT07613931

Knowledge-focused Sponsor: Tactile Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 5 times

Summary

This pilot study tests whether a new compression pattern in a leg sleeve device (Flexitouch Plus) moves lymph fluid better than the current version. Five adults with leg lymphedema will receive both treatments in separate visits, and doctors will measure how far and how often lymph travels using a special dye. The goal is to see if the updated firmware improves fluid drainage.

What this could mean

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

Active substance
Advanced pneumatic compression device (Flexitouch Plus) with novel multi-chamber firmware
What this could lead to
If successful, this could point toward a more effective way to manage lymphedema swelling using improved compression technology.
What could go wrong
This is a very early pilot study with only 5 participants, so results may not apply to everyone. The new firmware might not improve lymph flow as hoped.
Why investors are watching

Tactile Medical is testing whether a revised firmware for its Flexitouch Plus device improves lymph movement in patients with lower extremity lymphedema. For a small company whose main product is this compression device, a positive result could strengthen its position in the lymphedema market. The trial is tiny, with only 5 participants, so it is an early signal rather than a definitive proof.

If it works: A positive result could show that the new firmware meaningfully improves lymphatic function, giving Tactile Medical a reason to pursue a larger study and potentially a product upgrade. That could help the company differentiate its device from competitors.

If it fails: The trial could fail to show a clear improvement, or the small sample size could produce inconclusive data. Trials at this stage often fail, and a weak result could delay any product update and leave the company without a new selling point.

AI-written from the trial record. Speculative, and not investment advice.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

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: 1. 18 years of age or older 2. A diagnosis of active lower extremity lymphedema, as assessed by medical history 3. Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use 4. Must be able to provide informed consent prior to study participation 5. Willing and able to comply with the study protocol requirements and all study-related visit requirements Exclusion Criteria: 1. Heart failure (acute pulmonary edema, decompensated acute heart failure) 2. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 3. Severe peripheral artery disease (critical limb ischemia, including ischemic rest pain, arterial wounds or gangrene) 4. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the trunk or lower extremities 5. Active cancer or metastasis in the lower extremity lymphatic watersheds 6. Eczema, rash, scarring, or extensive tattoos at imaging sites 7. Participant is pregnant or trying to become pregnant 8. Participants with a history of allergy to iodides, who may be susceptible to iodine present in ICG formulation 9. Patients exhibiting Grade 3 or higher on the CTCAE v6.0 superficial soft tissue fibrosis scale 10. Body Mass Index (BMI) ≥40 11. Participants unable to recline on their backs for up to 60 consecutive minutes and walk in place or tolerate assisted lower extremity movement for 5 minutes

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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.

Lower extremity lymphedema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • UTHealth Houston (The University of Texas Health Science Center at Houston)

    RECRUITING

    Houston, Texas, 77030, United States

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