NCT04012723

Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome

Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients With an Upper or Lower Extremity Fracture at Risk for Acute Compartment Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: MY01 Inc. · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Compartment Syndrome Traumatic Lower Extremity
• Compartment Syndrome Traumatic Upper Extremity

Interventions

Type	Name	Description
DEVICE	MY01 Continuous Compartmental Pressure Monitor	The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.

Timeline

• Start date: 2020-11-17
• Primary completion: 2022-11-30
• Completion: 2023-03-30
• First posted: 2019-07-09
• Last updated: 2024-02-21

Locations

5 sites across 1 country: Canada