Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities
Megadott ok: The termination is based on a shifted commercial interest of the Sponsor and is not related to any safety grounds.
Key facts
- Where
- Berlin, Erlangen és Jena, NémetországSee the 3 sites
Where in Németország
- Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30Berlin, NémetországNo longer taking part
- Universitätsklinikum Erlangen Medizinische Klinik 1Erlangen, NémetországNo longer taking part
- Universitätsklinikum JenaJena, NémetországNo longer taking part
Trial details
- Who runs it
- iThera Medical GmbH
- Trial code
- NCT04456400
- Record updated
- 2025. május 2.
- Original description
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 toRead full original descriptionShow less
Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)
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
Inclusion: 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: 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); Medication leading to increased light sensitivity; Indeterminate Colitis, irritable bowel syndrome (IBS); Skin lesions, scar tissue or skin diseases affecting the area of imaging; Exclusion due to safety concerns of investigator (subject who has any condition, including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study); Stoma independent of localization, ileoanal pouch; Involvement of the upper gastrointestinal (GI) track only; Isolated proctitis; Complications, such as infectious enteritis, infectious colitis and infectious enterocolitis, abscess formation, intestinal obstruction, toxic megacolon; Tattoo in skin area of interest; Highly pigmented skin in the area of imaging (e.g. Fitzpatrick skin type V and VI); The bowel wall is invisible in the Ultrasound image of the MSOT system; Pregnant and breastfeeding women; Mental retardation of the patient with restriction of general judgment and awareness.