Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease (MA-51)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00487396
First received: June 14, 2007
Last updated: April 17, 2012
Last verified: March 2012
  Purpose

The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and diarrhea.

The primary objective of the study is to evaluate whether Capsule Endoscopy prior to colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to standard diagnostic testing.


Condition Intervention
Crohn's Disease
Device: Capsule Endoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • The Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related [ Time Frame: four months from enrollment ] [ Designated as safety issue: No ]
    The number of positive findings related to Crohn that were detected by capsule endoscopy procedure and ileo-colonoscopy as compared to the number of findings related to Crohn that were detected by ileo-colonoscopy and small bowel follow through(SBFT) procedures.


Secondary Outcome Measures:
  • Small Bowel Disease Present (Will be Categorized as Mild, Moderate or Severe)or Suspicious for Small Bowel Disease or No Small Bowel Disease Present. [ Time Frame: four months from enrollment ] [ Designated as safety issue: No ]
  • The Additional Diagnostic Value and Sensitivity of CE Compared With Ileo-colonoscopy and SBFT Will be Evaluated by the Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related. [ Time Frame: four months from enrollment ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: September 2007
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Capsule Endoscopy
    Pillcam Platform with RAPID5 software and supporting SB2 capsules
Detailed Description:

Crohn's disease is a chronic, inflammatory disorder(IBD) affecting any part of the gastrointestinal tract but frequently involves the small and large bowel. (1,2,3) Typical presenting symptoms include abdominal pain and diarrhea. (1,2,3) Patients with this disorder may also have extraintestinal manifestations including arthritis, uveitis and aphthous stomatitis, erythema nodosum and pyoderma gangrenosum.(1,2) The etiology of Crohn's disease is unknown. It affects populations around the globe and occurs at any age but it has a predilection to affect those between the ages of 15 and 35. (1,2,3,4) While about one half of patients have involvement of the ileum and large bowel, another third have disease isolated to the small bowel. (1,2) Frequently, small bowel Crohn's disease can be difficult to diagnose using the traditional methods of evaluation including colonoscopy with ileoscopy and contrast radiography.(1,2) Mucosal features of Crohn's disease are often subtle and difficult to identify by small bowel follow through (SBFT). The SBFT has traditionally been relied on to evaluate the small intestine for evidence of Crohn's disease but it has been shown to have a relatively low accuracy of only 30%. (5,6,7,8,9,) This has led to delays in the diagnosis of Crohn's disease with reports ranging from one to three years.(7,8,9) In the past few years, capsule endoscopy has sparked renewed interest in the investigation of IBD and Crohn's disease of the small bowel. A PillCam™ SB2 capsule (Given Imaging Ltd, Yoqneam, Israel) is an ingestible, disposable video camera that transmits high quality images of the small intestinal mucosa. This enables the small intestine to be readily accessible to physicians investigating for the presence of small bowel disorders which in the past was inaccessible to physicians.(7,9,10,11,12) A number of small pilot studies demonstrated capsule endoscopy efficacy in diagnosing SB Crohn's disease. Diagnostic yields of 70% have been reported in small series of studies performed in suspected small bowel Crohn's disease.( 9,10,11,12) This study is designed to determine the yield and clinical impact of Capsule Endoscopy in detecting suspected IBD and suspected Crohn's Disease of the small bowel when compared to SBFT. (6,7,8,9,10)

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ages 10-65 years, inclusive

    • Patient suffers from either

      • diarrhea for more than 6 weeks and less than 3 years and/or
      • abdominal pain for more than 6 weeks and less than 3 years and/or
      • extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis
    • Patient suffers from at least one of the symptoms / lab abnormalities listed below:

      • Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment
      • Unexplained anemia (less than normal limits) within 3 months prior to enrollment
      • Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment
      • Positive ASCA within 3 months of enrollment
      • Abnormal white blood cell scan with in 3 months of enrollment
      • Stool negative for O&P (C&S) within 3 months of enrollment
      • Recurrent Fevers
      • Unexplained weight loss, failure to thrive in children
      • Gastro-intestinal bleeding including melena and/or hematochezia and/or FOBT positive.
      • Chronic perianal disease (fistula, fissure, peri-rectal abscess)
      • Abnormal small bowel SBFT and/or enteroclysis and/or abdominal CT not conclusively diagnostic for IBD
    • Patient is indicated for Ileo-Colonoscopy
    • Patient or legal guardian agrees to sign consent form

Exclusion criteria:

  • Indeterminate Colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met
  • Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting.
  • Definite long stricture seen on radiological exam.
  • Suspected GI stricture, followed by agile™ study that could not prove patency of the GI tract.
  • Known history of small bowel Crohn's Disease
  • Current treatment for active IBD
  • Positive Anti-tTG or anti-endomysial antibody
  • Any of the following work-up within 1 year of study entry: Capsule Endoscopy, Colonoscopy and Upper GI/SBFT.
  • Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
  • Patient is pregnant
  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: NCT00487396

Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 10128
United States, Georgia
Stan Cohen
Atlanta, Georgia, United States, 30342
Atlanta Gastroenterology
Atlanta, Georgia, United States, 30342
United States, Maryland
John Hopkins - Department of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01612
United States, Minnesota
Minnesota Gastroenterology Associates
Plymouth, Minnesota, United States, 55446
United States, New York
Private Practice
New York, New York, United States, 10128
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Israel
Rambam Medical Center
Haifa, Israel, 31096
Sweden
Malmo University Hospital UMAS
Malmo, Sweden, 20502
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Jonathan Leighton, MD Mayo Clinic
Principal Investigator: Peter Legnani, MD Private Practice New York, New York
  More Information

No publications provided by Given Imaging Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00487396     History of Changes
Other Study ID Numbers: MA-51
Study First Received: June 14, 2007
Results First Received: March 20, 2012
Last Updated: April 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
capsule endoscopy
Crohn's disease
small bowel disease
inflammatory bowel disease
Patients with suspected small bowel Crohn's disease

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

ClinicalTrials.gov processed this record on August 27, 2014