Crohn's Disease and Colitis Trial, Recruiting NCT03256240 Sponsor: Weill Medical College of Cornell University Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT03256240
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have Crohn's disease affecting the small intestine (ileum) or both the small intestine and part of the large intestine, and who need surgery for the first time to remove the affected section.
  • People aged 18 years or older, both male and female.
  • People with any type of Crohn's disease pattern — including the non-narrowing type, the narrowing type, or the type that causes tunnels or passages to form between organs.
  • People who are taking any medications before surgery, including medicines that block a substance called TNF (a type of anti-inflammatory treatment).

Who may not be able to join:

  • People under 18 years of age.
  • People who have had Crohn's disease surgery before and the disease has come back.
  • People who are pregnant.
  • People who have more than one separate area of active disease in the bowel, meaning they would need more than one surgical procedure at the same time.
  • People whose Crohn's disease extends into the first part of the large intestine (the cecum and ascending colon).
  • People who are expected to need ongoing preventive medical treatment after surgery.
  • People whose planned surgical procedure needs to be changed once the surgeon examines the inside of the abdomen during the operation.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Fabrizio Michelassi, MD, Weill Medical College of Cornell University

Phone: 646-962-2342

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
12 March 2014
Est. completion
31 July 2030

Where this trial is recruiting

🇧🇪 Belgium 🇫🇮 Finland 🇩🇪 Germany 🇮🇹 Italy 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery; Number of subjects with surgical recurrence at 60 months; Number of subjects with surgical recurrence at 120 months; Mucosal Healing GHS; Mucosal Healing IBD-DCA; Surgical Pathology Margins

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov