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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Derivation Cohort: derive optimum diagnostic MSOT thresholds

Timeframe: 5-10 days

Validation cohort: re-assess the diagnostic accuracy of MSOT

Timeframe: 5-10 days

Trial details

NCT IDNCT04456400

SponsoriThera Medical GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-25

View on ClinicalTrials.gov More Inflammatory Bowel Diseases trials