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

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ClinicalTrials.gov Identifier: NCT04012723
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
MY01 Inc.

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.

Condition or disease Intervention/treatment Phase
Compartment Syndrome Traumatic Lower Extremity Compartment Syndrome Traumatic Upper Extremity Device: MY01 Continuous Compartmental Pressure Monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MY01 Device

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




Primary Outcome Measures :
  1. Clinical ease with which the MY01 device is able to be inserted into a compartment. [ Time Frame: 24-48 hours following device insertion. ]

    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.


  2. Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone. [ Time Frame: 24-48 hours following device insertion. ]
    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.

  3. The change in intracompartmental pressure. [ Time Frame: 24-48 hours following device insertion. ]
    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.


Secondary Outcome Measures :
  1. Adverse events associated with the use of the device. [ Time Frame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment. ]
    The patient will be monitored for adverse events during treatment, and will be reassessed during the final follow-up of the participant at the first return visit to the fracture clinic. An adverse event constitutes "Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal lab findings) in participants, users or other persons, whether or not related to the investigational device."

  2. Pain at insertion site. [ Time Frame: 24-48 hours following device insertion. ]
    Participants will be asked to keep a diary while the device is in situ. The diary will consist of a pain Visual Analog Score (VAS) to be completed each time their vitals are taken, with space to freely comment on the device. VAS will be on a sliding scale where [0=no pain] and [10=pain as bad as it can be].



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012723


Contacts
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Contact: Cooper Jefferson 7057902959 cooper.jefferson@nxtsens.com
Contact: Kelly Trask 902-473-3161 kelly.trask@nshealth.ca

Locations
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Canada, Nova Scotia
Halifax Infirmary Completed
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
MY01 Inc.
Nova Scotia Health Authority
Investigators
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Principal Investigator: Ross Leighton, MD Orthopaedic Surgeon, Nova Scotia Health Authority

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Responsible Party: MY01 Inc.
ClinicalTrials.gov Identifier: NCT04012723     History of Changes
Other Study ID Numbers: MY01-NS-01
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MY01 Inc.:
Acute Compartment Syndrome

Additional relevant MeSH terms:
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Syndrome
Compartment Syndromes
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases