Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (NCT04456400) | Clinical Trial Compass
TerminatedNot Applicable
Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities
Stopped: The termination is based on a shifted commercial interest of the Sponsor and is not related to any safety grounds.
Germany, Italy200 participantsStarted 2021-02-03
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Established diagnosis of UC or CD for at least three months prior to enrollment
✓. Age ≥ 18 years
✓. Indication for endoscopy according to institutes routine care
✓. Written informed consent
Exclusion criteria
✕. Stoma independent of localization, ileoanal pouch
✕. Prior bowel surgery other than ileocecal resection, which potentially affects the study procedure by fundamentally changing bowel anatomy by removing the ROI (e.g. (partial) resection of the sigmoid, left sided colon) or repositioning the ROI to an inaccessible location (e.g. right-sided colectomy with transversostomy)