Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD
Not applicable · Testing IOUS-guided margin selection · 1 site · The Cleveland Clinic
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing IOUS-guided margin selection (a device) as a possible treatment. Condition(s) listed: Crohn's Disease (CD).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 22 participants are expected to take part.
- Start date: 2026-09 (planned).
- Main results expected around 2028-08 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- feasibility in ultrasound assessment of resection margin (Intraoperative / day of surgery)
In the researchers’ words
This is a Phase II, single-center (Cleveland Clinic), two-arm, randomized, parallel-group superiority trial. The two arms will compare IOUS-guided margin selection against standard macroscopic margin selection in patients undergoing ileocolic resection for terminal ileal Crohn's disease.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease (CD) |
| Lead sponsor | The Cleveland Clinic |
| Enrollment | 22 (estimated) |
| Start date | 2026-09 |
| Primary completion (est.) | 2028-08 |
| First posted | 2026-07-02 |
| Last updated | 2026-08-27 |
| Official title | Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial |
| ClinicalTrials.gov ID | NCT07680283 |
Interventions
- IOUS-guided margin selection (Device)
Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic | Cleveland, Ohio | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.