Compartment Syndrome Traumatic Lower ExtremityNCT04012723
Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
A study testing MY01 Continuous Compartmental Pressure Monitor in people with Compartment Syndrome Traumatic Lower Extremity and Compartment Syndrome Traumatic Upper Extremity, run by MY01 Inc. at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Compartment Syndrome Traumatic Lower Extremity, Compartment Syndrome Traumatic Upper Extremity
- 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
- 100 participants
- Where
- 5 sitesCanada
- Study dates
- 17 Nov 2020to 30 Mar 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
Halifax Infirmary
Halifax, Nova Scotia, B3H 1V7
London Health Sciences Centre
London, Ontario, N6A 5W9
Ottawa Civic Hospital
Ottawa, Ontario, K1Y 4E9
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
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
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
- 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
The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.
| Study group | Role | What they receive |
|---|---|---|
| MY01 Device | Experimental | Device: MY01 Device
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 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.
Measured: 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.
Measured: 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.
Measured: 24-48 hours following device insertion.
Secondary outcomes (2)
Adverse events associated with the use of the device.
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."
Measured: 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.
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].
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 posted9 Jul 2019
- Study start17 Nov 2020
- Primary completion30 Nov 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment Syndrome Traumatic Lower ExtremityStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MY01 Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor
- Investigators
- Ross Leighton, MD, Principal investigator, Orthopaedic Surgeon, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012723
- Sponsor's protocol ID
- MY01-NS-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
- 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
- ClinicalTrials.gov ID
- NCT04012723
- Acronym / sponsor ID
- MY01-NS-01
- Conditions
- Compartment Syndrome Traumatic Lower Extremity, Compartment Syndrome Traumatic Upper Extremity
- Keywords
- Acute Compartment Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MY01 Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 9 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 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.
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 MonitorDevice: MY01 Device Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 MonitorThe MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. | Device | MY01 Device |
Primary outcome
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.
2 secondary outcomes
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.
Pain at insertion site.
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 Compartment Syndrome Traumatic Lower Extremity
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BM-MNCs for Lower Extremity Compartment Syndrome Injury
Compartment Syndrome Traumatic Lower Extremity
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Gene Expression in Lower Extremity Acute Traumatic Compartment Syndrome
Tibial Shaft Fracture, Tibial Plateau Fracture
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.
Ross Leighton, MD principal investigator
Orthopaedic Surgeon, Nova Scotia Health Authority
5 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 Compartment Syndrome Traumatic Lower Extremity and Compartment Syndrome Traumatic Upper Extremity, run by MY01 Inc. at 5 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 4 inclusion and 4 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 5 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 MY01 device is able to be inserted into a 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.