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Device

OsciPulse system for Ischemic Stroke

Phase 2
Waitlist Available
Research Sponsored by OsciFlex LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial will test a new device to see if it is safe and effective at reducing a protein marker for clotting in stroke patients.

Eligible Conditions
  • Ischemic Stroke
  • Venous Thrombosis
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative change in serum d-dimer levels
Secondary outcome measures
Device tolerability
Other outcome measures
Device Safety event rate

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study ArmExperimental Treatment1 Intervention
Subjects will receive compression therapy from the OsciPulse system.
Group II: Control ArmActive Control1 Intervention
Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OsciPulse system
2022
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

OsciFlex LLCLead Sponsor
2 Previous Clinical Trials
39 Total Patients Enrolled
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,880,088 Total Patients Enrolled
5 Trials studying Ischemic Stroke
360 Patients Enrolled for Ischemic Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently recruiting participants?

"Contrary to expectations, the clinical trial detailed on clinicaltrials.gov is not currently recruiting participants. Initially posted in December 2022 and last updated 19th September of the same year, this medical research does not need more volunteers at present; however there are 491 other studies that require enrolment presently."

Answered by AI

To what extent might the OsciPulse system be a hazard to patients?

"Our assessment of the safety associated with OsciPulse system yielded a score of 2 due to its Phase 2 status, indicating that there is some evidence for security but no data demonstrating efficacy."

Answered by AI

Is participation in this medical trial open to individuals younger than 20 years old?

"To be considered for this trial, applicants must fall within the 18 to 100 years of age range. Moreover, there are 19 trials open to those under 18 and 473 that accept participants over 65."

Answered by AI

Is there an opportunity for me to volunteer for this research?

"For this clinical trial, 40 individuals aged 18 to 100 who have experienced a wake-up stroke are being recruited. To qualify for the study, patients must also meet certain additional criteria including having had their last known normal state less than 24 hours ago, an NIH Stroke Score of at least 5 points, be prescribed mechanical therapy for DVT prevention, demonstrate weakness in one or more legs as indicated by 1 point on the NIHSS lower extremity motor scores (6A and 6B)."

Answered by AI
~0 spots leftby Apr 2025