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Clinical Trial Summary

The clinical investigation aims to generate clinical data to support the use of Multispectral Optoacoustic Tomography (MSOT) in clinical practice, its inclusion in diagnostic guidelines and to support its reimbursement, specifically to - Further validate the application with respect to including ulcerative colitis patients - Prepare a study protocol for large-scale clinical validation study in inflammatory bowel disease (IBD) - Successfully execute the clinical validation study


Clinical Trial Description

The clinical investigation, EUPHORIA, will pave the way to establish Multispectral Optoacoustic Tomography (MSOT) technology for the non-invasive assessment of intestinal inflammation in patients. EUPHORIA will enable commercialization of the technology by finalizing technical improvements that will increase diagnostic outcome beyond what has been shown in a first feasibility study, will improve usability, prepare CE marking for the new device and validate clinical results in a large clinical investigation. Inflammatory bowel disease (IBD) is a chronic condition, posing significant burden to patients and health care systems. Patients suffer from a relapsing course of intestinal inflammation, and to date, there is no satisfying noninvasive diagnostic modality for monitoring disease activity. In a recent clinical study conducted by University Hospital Erlangen, MSOT, a technology developed by iThera Medical (ITM), has proven to be superior in diagnostic performance to other procedures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04456400
Study type Observational
Source iThera Medical GmbH
Contact
Status Suspended
Phase
Start date February 3, 2021
Completion date April 2024

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