Status:
TERMINATED
Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities
Lead Sponsor:
iThera Medical GmbH
Collaborating Sponsors:
European Commission
Conditions:
Inflammatory Bowel Diseases
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief 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...
Detailed 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. EUP...
Eligibility Criteria
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
- 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)
- Indeterminate Colitis, irritable bowel syndrome (IBS)
- 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
- Skin lesions, scar tissue or skin diseases affecting the area of imaging
- 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
- Medication leading to increased light sensitivity
- Pregnant and breastfeeding women
- Mental retardation of the patient with restriction of general judgment and awareness
- 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)
Key Trial Info
Start Date :
February 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04456400
Start Date
February 3 2021
End Date
April 25 2025
Last Update
May 2 2025
Active Locations (6)
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1
Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30
Berlin, Germany, 12203
2
Universitätsklinikum Erlangen Medizinische Klinik 1
Erlangen, Germany, 91054
3
Universitätsklinikum Jena
Jena, Germany, 07747
4
Policlinico Tor Vergata
Rome, Lazio, Italy, 00133