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Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD

NCT07680283 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-08-27

No results posted yet for this study

Summary

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. Patients and outcome assessors (pathologists, endoscopists) will be blinded to the intervention arm, while surgeons, by the nature of the intervention, cannot be blinded. Randomization will be computer-generated with concealed allocation using permuted blocks to ensure balanced group sizes.

Conditions

  • Crohn's Disease (CD)

Interventions

DEVICE

IOUS-guided margin selection

Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-08-31
Completion
2029-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07680283 on ClinicalTrials.gov