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Sound waves could replace biopsies for gut scarring detection

NCT ID NCT06516237

Knowledge-focused Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study explores whether ultrasound and elastography can detect fibrosis (scarring) in the gut of people with ulcerative colitis. Researchers will compare ultrasound images with tissue samples from biopsies to find new biomarkers. The goal is to develop a non-invasive method to assess disease severity, potentially reducing the need for repeated colonoscopies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a non-invasive way to detect fibrosis in ulcerative colitis using ultrasound, reducing the need for biopsies.
What could go wrong
This is an early-stage observational study with only 50 participants. The findings may not apply to all patients or lead to immediate clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult, 18 years of age and older, * Established diagnosis (\> three months) of ulcerative colitis, * Performing colonoscopy, according to current standards of care and ECCO guidelines, * Ability to understand and comply with the study procedure and sign an informed consent form Exclusion Criteria: * Pregnancy, * presence of ascites, active infections, any contraindication to colonoscopy (e.g. intolerance to preparation, severe flare), * inability to undergo intestinal ultrasound within the time set by the study, * poor quality of ultrasound imaging (due to luminal gas or body habitus), or a diagnosis of malignancy in the pathological specimen. * subjects who needs to change therapy

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS San Raffaele Hospital, Milano

    RECRUITING

    Milan, Lombardy, 20132, Italy

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