An interventional study of MY01 - Continuous Compartmental Pressure Monitor in Acute Compartment Syndrome, sponsored by MY01 Inc.. Completed at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by MY01 Inc. · Not applicable, Interventional, and Other
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.
75 studies on the registry are indexed under Compartment Syndromes; 12 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 43 interventional studies indexed under Compartment Syndromes.
Browse Compartment Syndromes studies →MY01 Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure
Device: MY01 - Continuous Compartmental Pressure Monitor
Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure
Clinical ease with which the new compartment pressure monitor was inserted into 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 the device functioned adequately?" \[0 = not confident\] - \[10 = very confident\]. 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 10 should be considered a very positive scenario, whereas a record of 0 should indicate a very negative scenario.
Time frame: 24-48 hours following device insertion
Ability to monitor in real-time the continuous pressure read-out from the compartment in remote locations such as an I-phone.
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 in a Yes or No question "Did the MY01 Application remote data display work properly?" \[Yes\] or \[No\].
Time frame: 24-48 hours following device insertion
The correlation of continuous pressure read-outs (high, normal or low) with clinical indications for compartment syndrome in each patient.
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.
Time frame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
Correlation of clinical compartment syndrome release with data from the continuous pressure monitor read-out.
Should surgical fasciotomy be deemed necessary to release pent up pressure in the patients muscle compartment, the continuous pressure read-outs \[mmHG\] derived from the device will be compared against the timeframe when the decision to conduct fasciotomy was made.
Time frame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
Short-term outcomes of the patient following continuous pressure monitoring
Survey and tabulation of data from patient clinical findings.
Time frame: 24-48 hours following device insertion.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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MY01 Inc.