Compartment SyndromesNCT05367921
SWISS_EVIDENCE - Compartment Compressibility Monitoring Using CPM#1
A study testing Measurement of compartment compressibility in people with Compartment Syndromes, run by Compremium AG at 1 site in Switzerland.
Trial summary
Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Compartment Syndromes
- What is being tested?
- Measurement of compartment compressibility
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 May 2022to 17 May 2022
- 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Male and female
- Age between 18 and 84
Who cannot join
- Previous surgery to or fracture of the lower leg
- Peripheral arterial or venous disease
- History of compartment syndrome
- Limb anomalies
- General muscle disorder
- Participants under the influence of excessive alcohol, consumption of narcotics or benzodiazepines prior to procedure
- Participants under the effect of analgesic (< 12 hours)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital
Bern, 3010
About this study
Official title: Clinical Validation of CPM#1 Compression Ratio Measurement on Healthy Volunteers
Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.
Even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. Furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. The concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra-compartmental pressure within 6 to 10 hours.
Read more
The standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. Commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common.
Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring System (CPM#1) shows promising advantages for the clinical application. Not only is the technology used for the CPM#1 device safe and non-invasive for the patient with minimal training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.
- Conditions
- Compartment Syndromes
- Being tested
- Measurement of compartment compressibility
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of compartment compressibilityDevice
Application of the CPM#1 device for compartment compressibility ratio measurement - 4 measurements on both legs of each healthy volunteer will be performed
| Study group | Role | What they receive |
|---|---|---|
| CPM#1 | Experimental | Compartment compressibility ratio measurement using the CPM#1 device Receives: Device: Measurement of compartment compressibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-operator reproducibility with 3 raters
Inter-operator reproducibility will be assessed using intra-class correlation coefficients (two-way random effects, single rater, absolute agreement). Three independent raters will conduct one measurement on each of both legs of 21 volunteers.
Measured: During the procedure which should last about 10 min/patient
Secondary outcomes (4)
Intra-operator reproducibility
Intra-operator reproducibility will be assessed using intra-class correlation coefficients (two-way mixed effects, single measurement, absolute agreement). One of the three independent raters will conduct two measurements on 42 legs (21 volunteers).
Measured: During the procedure which should last about 10 min/patient
Participant's reported pain: baseline
Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points.
Measured: Before (5 min before procedure).
Participant's reported pain: at highest externally applied pressure
Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points.
Measured: During the procedure (the procedure will last about 10 min/patient)
Participant's reported pain: after the procedure
Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points.
Measured: Immediately after procedure (no follow up is planned)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start4 May 2022
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment SyndromesStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compremium AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Anwander, Dr. med., Principal investigator, Department für Orthopädie und Traumatologie, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367921
- Sponsor's protocol ID
- SWISS_EVIDENCE
- Status last verified
- May 2022
- First submitted
- 25 Apr 2022
- Last updated
- 20 May 2022
- 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of CPM#1 Compression Ratio Measurement on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05367921
- Acronym / sponsor ID
- SWISS_EVIDENCE
- Conditions
- Compartment Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Compremium AGIndustry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 10 May 2022 (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 is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.
Even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. Furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. The concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra-compartmental pressure within 6 to 10 hours.
The standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. Commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common.
Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring System (CPM#1) shows promising advantages for the clinical application. Not only is the technology used for the CPM#1 device safe and non-invasive for the patient with minimal training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPM#1 | Experimental | Device: Measurement of compartment compressibilityCompartment compressibility ratio measurement using the CPM#1 device |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Male and female
- Age between 18 and 84
Key exclusion criteria (7 listed)
- Previous surgery to or fracture of the lower leg
- Peripheral arterial or venous disease
- History of compartment syndrome
- Limb anomalies
- General muscle disorder
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 |
|---|---|---|
| Measurement of compartment compressibilityApplication of the CPM#1 device for compartment compressibility ratio measurement - 4 measurements on both legs of each healthy volunteer will be performed | Device | CPM#1 |
Primary outcome
Inter-operator reproducibility with 3 raters
Time frame: During the procedure which should last about 10 min/patient
Inter-operator reproducibility will be assessed using intra-class correlation coefficients (two-way random effects, single rater, absolute agreement). Three independent raters will conduct one measurement on each of both legs of 21 volunteers.
4 secondary outcomes
Intra-operator reproducibility
Time frame: During the procedure which should last about 10 min/patient
Participant's reported pain: baseline
Time frame: Before (5 min before procedure).
Participant's reported pain: at highest externally applied pressure
Time frame: During the procedure (the procedure will last about 10 min/patient)
Participant's reported pain: after the procedure
Time frame: Immediately after procedure (no follow up is planned)
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 20 May 2022.
- Individual participant dataSharing planned: No
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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.
Helen Anwander, Dr. med. principal investigator
Department für Orthopädie und Traumatologie, Inselspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of compartment compressibility in people with Compartment Syndromes, run by Compremium AG at 1 site in Switzerland.
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 7 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 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Inter-operator reproducibility with 3 raters (time frame: During the procedure which should last about 10 min/patient). 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 20 May 2022.