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

NCT04012723 | Completed

• 1 other identifier: MY01-NS-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Acute Compartment Syndrome

Outcome Measures

Primary Outcomes (3)

• Clinical ease with which the MY01 device is able to be inserted into a compartment.

  At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate on a sliding scale "How certain are you that the sensor is in the correction position?" \[1 = uncertain\] - \[5 = very certain\]. The scale, administered part of a Clinical Report Form (CRF) titled 'Physician Survey', measures the physicians subjective level of certainty that the device sensor was inserted correctly within a patients muscle compartment. A record of 5 should be considered a positive scenario, whereas a record of 1 should indicate a negative scenario.

  24-48 hours following device insertion.

• Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.

  At insertion of device the physician will complete a feedback questionnaire on the device, the participant will be assessed for adverse events, and routine assessment will be performed.

  24-48 hours following device insertion.

• The change in intracompartmental pressure.

  Routine assessments will be completed by healthcare personnel as per standard of care (the 6P's \[Pain, Paraesthesia, Pallor, Paralysis, Pulselessness, Poikilothermia\]), and compared against the pressure readout \[mmHG\] indicated by MY01's MicroElectroMechanical (MEMS) pressure sensor inserted at the afflicted location.

  24-48 hours following device insertion.

Secondary Outcomes (2)

• Adverse events associated with the use of the device.

  24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment.

• Pain at insertion site.

  24-48 hours following device insertion.

Study Arms (1)

MY01 Device

EXPERIMENTAL

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

Device: MY01 Continuous Compartmental Pressure Monitor

Interventions

MY01 Continuous Compartmental Pressure Monitor DEVICE

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

MY01 Device

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MY01 Inc.: lead
• Nova Scotia Health Authority: collaborator

Study Sites (5)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Halifax Infirmary

Halifax, Nova Scotia, B3H 1V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Study Officials

• Ross Leighton, MD

  Orthopaedic Surgeon, Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 9, 2019
• Study Start: November 17, 2020
• Primary Completion: November 30, 2022
• Study Completion: March 30, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)