NCT05483946

SWISS_CLEARANCE - Compartment Compressibility Monitoring Using CPM#1

Validation of CPM#1 Compressibility Ratio in a Clinical Study of Healthy Volunteers: Evaluation of the Test-retest Repeatability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Compremium AG · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

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 only initial 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

Interventions

Type	Name	Description
DEVICE	Measurement of compartment compressibility	Application of the CPM#1 device for compartment compressibility ratio measurement - for each participant, a pre-defined number of measurements will be conducted per leg and forearm

Timeline

• Start date: 2022-11-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2022-08-02
• Last updated: 2022-11-08

Locations

1 site across 1 country: Switzerland