Diagnostic Accuracy of Capsule Endoscopy in Small Bowel Crohn's Disease

Completed · Phase 4

Conditions studied: Crohn's Disease

In brief

Prospective study to compare in a blinded fashion four different diagnostic modalities to detect active small bowel Crohn's disease: a) colonoscopy with ileoscopy; b) small bowel follow through; c) capsule endoscopy; and d) computed tomography enterography.

Key facts

Study ID

NCT00588653

Run by

Mayo Clinic

People needed

41

Starts

2004-01-01

Expected to finish

2004-08-01

Last updated by the study team

2008-01-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatient of either sex aged 18 to 70 years
• Patient has suspected or definite Crohn's disease
• Patient has read, understood, and signed a written informed consent form at visit 1.

You may not qualify if…

• Pregnancy
• Patients who are prisoners, institutionalized individuals, or vulnerable adults
• Patients immediately in need of abdominal surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, perforation, or intra-abdominal abscess
• Patients with known or suspected gastrointestinal obstruction due to significant stricture based upon the clinical symptoms (nausea, vomiting, abdominal distention, or abdominal pain) confirmed by pre-procedure evaluation. Pre-procedure evaluation includes CT enterography or small bowel follow through performed at Mayo or previously at an outside institution which demonstrates mechanical obstruction (mechanical obstruction defined as small bowel narrowing with pre-stenotic dilatation); additionally, a high-grade stenotic ileocecal valve or ileocolonic anastomosis found by colonoscopy.
• Patients with history of abdominal radiation
• Patients with known or suspected oropharyngeal or esophageal dysphagia (unless recent EGD shows no evidence of mechanical obstruction of the esophagus, in cases of esophageal dysphagia)
• Patients with pacemakers or other implantable electromedical devices
• Patients with highly suspected or documented gastroparesis
• Patients who have used NSAIDs within the previous 2 weeks
• Patients with an anticipated need for an MRI scan within two weeks after M2A capsule ingestion (for patients who require a clinically indicated MRI, the MRI should be performed prior to administration of the M2A capsule)
• Patients with a creatinine ≥ 2.0.
• Patients with documented reaction to iodinated contrast material.
• Patients with an ileostomy or colostomy
• Patients with documented reaction to metoclopramide.
• Patients with a hemoglobin less than 7.5 g/dl. (Patients with Crohn's disease are often chronically anemic, and a hemoglobin of 7.5 g/dl or greater would allow these patients to safely participate in the study.)

Where it is running

• Mayo Clinic Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.