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New device aims to prevent clots in stroke patients

NCT ID NCT06477016

Disease control Sponsor: University of Pennsylvania 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a new device called OsciPulse that rapidly compresses the calves to improve blood flow and reduce the risk of blood clots in people hospitalized after a stroke. About 40 adults with leg weakness will be randomly assigned to receive either OsciPulse or standard compression therapy. The main goal is to see if OsciPulse lowers a blood-clot marker called D-dimer more than standard care.

What this could mean

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

Active substance
OsciPulse device (non-invasive leg compression)
What this could lead to
If it works, this could offer a better way to prevent dangerous blood clots in stroke patients who cannot move their legs.
What could go wrong
This is a very small pilot study with only 40 people, so results may not apply widely. The device may be no better than standard compression or may be uncomfortable for 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.

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

About 40 people

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

Started

Feb 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

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

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. Adult aged ≥ 18 years old 2. Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke 3. \< 24 hours from last known normal or treating-hospital admission. 4. NIH stroke score ≥5 5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores) 6. Prescribed mechanical therapy for DVT prophylaxis. Exclusion Criteria: 1\. Inability or contraindication to applying IPC to both legs such as: * Evidence of acute bone fracture in lower extremities * Acute burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, in the lower extremities at the site of IPC placement * Acute ischemia or severe peripheral vascular disease in the lower extremities as evidenced by cyanotic, cool, pulselessness. * Amputated foot or leg on one or two sides * Compartment syndrome (acute injury causing swelling and ischemic injury) * Severe lower extremity edema (+4 edema as documented by clinical team) * Acute deep vein thrombosis 2. Subjects who received thrombolytic therapy for their stroke 3. Known pregnancy or within 6 weeks of postpartum period. 4. Limitation of life support, life expectancy \< 7 days, or in hospice care 5. A head-unit is unavailable within 24 hours of study enrollment. 6. At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Ischemic stroke

Contacts and locations

Locations

  • HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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