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

MY01 Inc.

Status: Completed

Conditions: Compartment Syndrome Traumatic Lower Extremity; Compartment Syndrome Traumatic Upper Extremity

Treatments: Device: MY01 Continuous Compartmental Pressure Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04012723

MY01-NS-01

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Planned admission to hospital (to enable monitoring of compartment pressures)
• Provision of informed consent to participate.

Exclusion criteria

• Frankly contaminated or infected wounds or fractures.
• Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
• Current or pre-existing neuropathy in the study limb.
• Pregnant women.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

MY01 Device

Experimental group

Description:

Device: MY01 Device Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure

Treatment:

Device: MY01 Continuous Compartmental Pressure Monitor