SWISS_CLEARANCE – Compartment Compressibility Monitoring Using CPM#1

Brief Title

SWISS_CLEARANCE - Compartment Compressibility Monitoring Using CPM#1

Official Title

Validation of CMP#1 Compression Ratio in a Clinical Study of Healthy Volunteers

Brief 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.

      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 Type

Interventional


Primary Outcome

Inter-operator reproducibility with 3 raters

Secondary Outcome

 Intra-operator reproducibility

Condition

Compartment Syndromes

Intervention

Measurement of compartment compressibility

Study Arms / Comparison Groups

 CPM#1
Description:  Compartment compressibility ratio measurement using the CPM#1 device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

13

Start Date

August 2022

Completion Date

October 2022

Primary Completion Date

October 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy volunteer

          -  Male or female

          -  Age 18 to 84 years

        Exclusion Criteria:

          -  Previous surgery to or fracture of the lower leg

          -  Peripheral arterial or venous disease

          -  History of compartment syndrome

          -  Limb anomalies

          -  General muscle disorder
      

Gender

All

Ages

18 Years - 84 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Beat Lehmann, +41 79 933 96 48, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT05483946

Organization ID

SWISS_CLEARANCE


Responsible Party

Sponsor

Study Sponsor

Compremium AG


Study Sponsor

Beat Lehmann, Principal Investigator, Universitäres Notfallzentrum, Inselspital Bern


Verification Date

July 2022