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
|Condition or disease||Intervention/treatment||Phase|
|Compartment Syndrome Traumatic Lower Extremity Compartment Syndrome Traumatic Upper Extremity||Device: MY01 Continuous Compartmental Pressure Monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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."
- 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].
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
|Contact: Cooper Jeffersonfirstname.lastname@example.org|
|Contact: Kelly Traskemail@example.com|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Principal Investigator:||Ross Leighton, MD||Orthopaedic Surgeon, Nova Scotia Health Authority|