Acute Compartment SyndromeNCT04016103
MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time
A study testing MY01 - Continuous Compartmental Pressure Monitor in people with Acute Compartment Syndrome, run by MY01 Inc. at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- MY01 - Continuous Compartmental Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 17 Jul 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, aged 18 years of age and older
- Any tibial, foot, femoral, forearm or fracture that is felt by the surgeon to have a reasonable indication that elevated ICP could occur in the patient
- Mentally fit to provide informed consent
Who cannot join
- Patients with fractures that are not felt to be at risk of developing compartment syndrome based on serial clinical evaluation
- Infected wounds; infected fractures
- Patients who present with ACS requiring urgent surgical fasciotomy
- Patients who cannot consent to trial
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, H4J 1C5
About this study
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
- Being tested
- MY01 - Continuous Compartmental Pressure Monitor
- Keywords
- Acute Compartment Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY01 - Continuous Compartmental Pressure MonitorDevice
Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure
| Study group | Role | What they receive |
|---|---|---|
| MY01 Device | Experimental | Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure Receives: Device: MY01 - Continuous Compartmental Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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].
Measured: 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.
Measured: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24-48 hours following device insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start17 Jul 2020
- Primary completion1 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Compartment SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MY01 Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Responsible party
- Sponsor
- Investigators
- Mitchell Bernstein, MD, Principal investigator, Staff Surgeon, Orthopaedic Trauma & Limb Deformity, Montreal General Hospital | Assistant Professor Department of Surgery and Pediatric Surgery McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016103
- Sponsor's protocol ID
- MY01 - QC - 01
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2019
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time
- ClinicalTrials.gov ID
- NCT04016103
- Acronym / sponsor ID
- MY01 - QC - 01
- Conditions
- Acute Compartment Syndrome
- Keywords
- Acute Compartment Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MY01 Inc.Industry (pharma, biotech, devices)
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MY01 Device | Experimental | Device: MY01 - Continuous Compartmental Pressure MonitorInsertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women, aged 18 years of age and older
- Any tibial, foot, femoral, forearm or fracture that is felt by the surgeon to have a reasonable indication that elevated ICP could occur in the patient
- Mentally fit to provide informed consent
Key exclusion criteria (5 listed)
- Patients with fractures that are not felt to be at risk of developing compartment syndrome based on serial clinical evaluation
- Infected wounds; infected fractures
- Patients who present with ACS requiring urgent surgical fasciotomy
- Patients who cannot consent to trial
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MY01 - Continuous Compartmental Pressure MonitorInsertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure | Device | MY01 Device |
Primary outcome
Clinical ease with which the new compartment pressure monitor was inserted into 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 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.
Ability to monitor in real-time the continuous pressure read-out from the compartment in remote locations such as an I-phone.
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 in a Yes or No question "Did the MY01 Application remote data display work properly?" [Yes] or [No].
The correlation of continuous pressure read-outs (high, normal or low) with clinical indications for compartment syndrome in each patient.
Time frame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
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.
2 secondary outcomes
Correlation of clinical compartment syndrome release with data from the continuous pressure monitor read-out.
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
Time frame: 24-48 hours following device insertion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Compartment Syndrome
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Recruiting
MY01 Pressure Monitoring in Adolescent Tibia Fractures
Proximal Tibia Fracture, Tibial Shaft Fracture
Enrolling by invitation
Gene Expression in Lower Extremity Acute Traumatic Compartment Syndrome
Tibial Shaft Fracture, Tibial Plateau Fracture
Recruiting
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
Acute Compartment Syndrome, Fracture, Bone
RecruitingObservational study
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
Compartment Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Bernstein, MD principal investigator
Staff Surgeon, Orthopaedic Trauma & Limb Deformity, Montreal General Hospital | Assistant Professor Department of Surgery and Pediatric Surgery McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MY01 - Continuous Compartmental Pressure Monitor in people with Acute Compartment Syndrome, run by MY01 Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical ease with which the new compartment pressure monitor was inserted into compartment. (time frame: 24-48 hours following device insertion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.