Ultrasound may help surgeons remove the right amount of bowel in Crohn's disease

NCT ID NCT07680283

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

First seen Jul 02, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This trial tests whether using ultrasound during surgery to choose where to cut the bowel leads to better outcomes for people with Crohn's disease. About 44 adults with Crohn's disease affecting the last part of the small intestine will be randomly assigned to have their surgery guided by ultrasound or by standard visual inspection. The main goal is to see if the ultrasound method is practical and reduces inflammation in the remaining bowel.

What this could mean

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

Active substance: Intra-operative ultrasound (IOUS)-guided margin selection
What this could lead to: If successful, this approach could reduce disease recurrence after surgery for Crohn's disease by removing more affected tissue.
What could go wrong: This is a small, early-phase trial at one center, so results may not apply broadly. The ultrasound technique may not always be feasible or improve outcomes.

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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 22 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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: * Adults aged ≥18 years. * Diagnosis of terminal ileal Crohn's disease with inflammatory or fibrostenotic phenotype localized to terminal ileum/ileocecal region and assessed on either preoperative imaging or during surgical exploration at the time of surgery. * Scheduled to undergo primary ileocolic resection. Exclusion Criteria: * Penetrating disease with abscess or complex fistula requiring complex resection. * Prior ileocolic resection. * Diagnosis of Crohn's colitis. * Pregnancy or inability to provide informed consent. * Stoma at or before randomization: Participants in whom a stoma is required before randomization (identified intra-operatively) will not be randomized and will be excluded from the trial. Stoma after randomization: If a stoma is created after randomization-either during the index operation or at re-operation for postoperative complications-the participant remains in the trial. All feasibility, histopathology, operative, and safety outcomes will be collected and analyzed in the assigned arm (ITT). However, these participants will not be evaluable for the endoscopic-recurrence endpoint; they will be listed as "not assessed for endoscopic recurrence (stoma)" with reasons documented. * Contraindication to IOUS (as determined by the surgeon).

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Conditions

The condition(s) this trial relates to.

Crohn disease Crohn ileitis Margins of Excision

As listed by the trial registrant

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

Crohn's disease (CD)

How to take part

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

The places running it

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

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

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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.

Ultrasound may help surgeons remove the right amount of bowel in Crohn's disease

What the study statuses mean