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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588653
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : January 8, 2008
Given Imaging Ltd.
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Device: Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Capsule Endoscopy in Small Bowel Crohn's Disease
Study Start Date : January 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
All patients were to undergo all 4 diagnostic modalities, and each of these was compared to the consensus clinical diagnosis. Readers of each modality were blinded to the results of the other 3.
Device: Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through
Each patient undergoes each of the 4 diagnostic modalities, but the readers are blinded to results of the other 3.

Primary Outcome Measures :
  1. Sensitivity, positive predictive value, and accuracy of capsule endoscopy, CT enterography, colonoscopy with ileoscopy, and small bowel follow through using a consensus clinical diagnosis of small bowel Crohn's disease as the reference standard.

Secondary Outcome Measures :
  1. Describe spectrum of right colon lesions visualized by capsule endoscopy in patients with Crohn's disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588653

United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Given Imaging Ltd.
Principal Investigator: Edward V Loftus, MD Mayo Clinic

Responsible Party: Edward V. Loftus, Jr., M.D., Mayo Clinic Identifier: NCT00588653     History of Changes
Other Study ID Numbers: 2018-03
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: December 2007

Keywords provided by Mayo Clinic:
Crohn's disease
capsule endoscopy
computed tomography enterography
small bowel follow-through

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases