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Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities

NCT04456400 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-05-02

No results posted yet for this study

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

Conditions

Interventions

DIAGNOSTIC_TEST

Multispectral Optoacoustic Tomography (MSOT)

cMSOT-2 system is indicated for measurement of the Multispectral Optoacoustic Tomography (MSOT) values in the bowel wall of patients with an established diagnosis of inflammatory bowel disease (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC). The MSOT values provided may be used as an aid to the assessment of inflammatory disease activity in the bowel wall.

Sponsors & Collaborators

Principal Investigators

  • Maximilian Waldner, Prof. Dr. · Universitätsklinikum Erlangen Medizinische Klinik 1

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2025-04-25
Completion
2025-04-25

Countries

  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456400 on ClinicalTrials.gov