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

This study has been completed.
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588653
First received: December 21, 2007
Last updated: January 7, 2008
Last verified: December 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Capsule Endoscopy in Small Bowel Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Describe spectrum of right colon lesions visualized by capsule endoscopy in patients with Crohn's disease. [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588653

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

No publications provided

Responsible Party: Edward V. Loftus, Jr., M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588653     History of Changes
Other Study ID Numbers: 2018-03
Study First Received: December 21, 2007
Last Updated: January 7, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 28, 2014