NCT04016103

MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: MY01 Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Compartment syndrome can result from extremity trauma. It can also be caused by procedural cases that involve lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions that can avoid complications. Subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve our accuracy in diagnosing compartment syndrome. Ideally, this would be suited for single and/or continuous pressure read-outs. The aim is to reduce the incidence of missed compartment syndrome and diminish delays that would lead to significant disability. Despite awareness, delayed diagnosis and treatment occurs in modern orthopaedic practice. As noted in many studies, once a diagnosis has been made, immediate fasciotomy is necessary to provide the best chance for a favourable clinical result. Therefore, there is a need for improved devices in order to obtain an early and reliable diagnosis.

Conditions

• Acute Compartment Syndrome

Interventions

Type	Name	Description
DEVICE	MY01 - Continuous Compartmental Pressure Monitor	Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure

Timeline

• Start date: 2020-07-17
• Primary completion: 2023-02-01
• Completion: 2023-06-30
• First posted: 2019-07-11
• Last updated: 2024-02-21

Locations

2 sites across 1 country: Canada