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MY01 Device for Lower Extremity Compartment Syndrome

N/A
Waitlist Available
Led By Ross Leighton, MD
Research Sponsored by MY01 Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults age 16-65.
Fracture of the tibia, foot, forearm, femur, or humerus that is felt by the surgeon to have a reasonable indication that elevated intracompartmental pressure could occur in the patient.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 hours following device insertion.
Awards & highlights

Study Summary

Compartment syndrome remains a very serious complication of lower extremity trauma and/or procedural cases that involved lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions to avoid complications. Unfortunately, the subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve the investigator's ability to diagnose this potentially devastating condition. The purpose of this trial is to evaluate the safety and functionality of MY01, an investigational device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. This is a single centre, non-randomized, non-controlled, unblinded, prospective trial of the MY01 device. A cohort of 25 participants will be prospectively enrolled to document the performance of the device.

Eligible Conditions
  • Lower Extremity Compartment Syndrome
  • Traumatic Compartment Syndrome of the Upper Extremity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours following device insertion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 hours following device insertion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.
Clinical ease with which the MY01 device is able to be inserted into a compartment.
The change in intracompartmental pressure.
Secondary outcome measures
Adverse events associated with the use of the device.
Pain at insertion site.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MY01 DeviceExperimental Treatment1 Intervention
Device: MY01 Device 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
~100

Find a Location

Who is running the clinical trial?

MY01 Inc.Lead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Nova Scotia Health AuthorityOTHER
254 Previous Clinical Trials
83,039 Total Patients Enrolled
Ross Leighton, MDPrincipal InvestigatorOrthopaedic Surgeon, Nova Scotia Health Authority
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~23 spots leftby Mar 2025