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Device
MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time
N/A
Waitlist Available
Led By Mitchell Bernstein, MD
Research Sponsored by MY01 Inc.
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 24-48 hours following device insertion
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device that may help improve the accuracy of diagnosing compartment syndrome.
Eligible Conditions
- Acute Compartment Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-48 hours following device insertion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours following device insertion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ability to monitor in real-time the continuous pressure read-out from the compartment in remote locations such as an I-phone.
Clinical ease with which the new compartment pressure monitor was inserted into compartment.
The correlation of continuous pressure read-outs (high, normal or low) with clinical indications for compartment syndrome in each patient.
Secondary study objectives
Correlation of clinical compartment syndrome release with data from the continuous pressure monitor read-out.
Short-term outcomes of the patient following continuous pressure monitoring
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MY01 DeviceExperimental Treatment1 Intervention
Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MY01 - Continuous Compartmental Pressure Monitor
2020
N/A
~50
Find a Location
Who is running the clinical trial?
MY01 Inc.Lead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Hopital du Sacre-Coeur de MontrealOTHER
51 Previous Clinical Trials
12,098 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
471 Previous Clinical Trials
166,907 Total Patients Enrolled
1 Trials studying Acute Compartment Syndrome
50 Patients Enrolled for Acute Compartment Syndrome
Mitchell Bernstein, MDPrincipal InvestigatorStaff Surgeon, Orthopaedic Trauma & Limb Deformity, Montreal General Hospital | Assistant Professor Department of Surgery and Pediatric Surgery McGill University