Study Arm for Wake-up Stroke

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Pennsylvania, Philadelphia, PA
Wake-up Stroke+3 More
OsciPulse system - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.

Eligible Conditions

  • Wake-up Stroke
  • Thromboses, Venous

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 7 days

7 days
Device Safety event rate
Device tolerability
Relative change in serum d-dimer levels

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Study Arm
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Study Arm · No Placebo Group · Phase 2

Study Arm
Device
Experimental Group · 1 Intervention: OsciPulse system · Intervention Types: Device
Control Arm
Device
ActiveComparator Group · 1 Intervention: Flowtron ACS900 · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days
Closest Location: University of Pennsylvania · Philadelphia, PA
Photo of Hospital of the University of Pennsylvania  1Photo of Hospital of the University of Pennsylvania  2Photo of University of Pennsylvania  3
2011First Recorded Clinical Trial
0 TrialsResearching Wake-up Stroke
1048 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have not had a normal bowel movement in the past 24 hours.
You must be a female aged ≥ 18 years old with a negative pregnancy test at screening.
You are admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke.
Weakness in at least one leg.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.