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出境医 / 临床实验 / Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
Study Description
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 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 25 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Start Date : | November 17, 2020 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | November 2021 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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].
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Cooper Jefferson | 7057902959 | cooper.jefferson@nxtsens.com | |
| Contact: Kelly Trask | 902-473-3161 | kelly.trask@nshealth.ca |
Locations
| Canada, Nova Scotia | |
| Halifax Infirmary | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Contact: Kelly Trask 902-473-3161 kelly.trask@nshealth.ca | |
| Contact: Shelley MacDonald 902-473-4098 shelleyl.macdonald@nshealth.ca | |
| Principal Investigator: Ross K Leighton, MD | |
Sponsors and Collaborators
MY01 Inc.
Nova Scotia Health Authority
Investigators
| Principal Investigator: | Ross Leighton, MD | Orthopaedic Surgeon, Nova Scotia Health Authority |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 3, 2019 | ||||||||
| First Posted Date ICMJE | July 9, 2019 | ||||||||
| Last Update Posted Date | December 21, 2020 | ||||||||
| Actual Study Start Date ICMJE | November 17, 2020 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE |
|
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| Intervention ICMJE | Device: MY01 Continuous Compartmental Pressure Monitor
The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.
|
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| Study Arms ICMJE | Experimental: MY01 Device
Device: MY01 Device Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure Intervention: Device: MY01 Continuous Compartmental Pressure Monitor
|
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
25 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | November 2021 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 16 Years to 65 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04012723 | ||||||||
| Other Study ID Numbers ICMJE | MY01-NS-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | MY01 Inc. | ||||||||
| Study Sponsor ICMJE | MY01 Inc. | ||||||||
| Collaborators ICMJE | Nova Scotia Health Authority | ||||||||
| Investigators ICMJE |
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| PRS Account | MY01 Inc. | ||||||||
| Verification Date | December 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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