Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease - Full Text View

Sponsor:	Given Imaging Ltd.
Information provided by:	Given Imaging Ltd.
ClinicalTrials.gov Identifier:	NCT00487396

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:	Diagnostic, Non-Randomized, Single Blind (Investigator), Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Colonoscopy Crohn's Disease Endoscopy

U.S. FDA Resources

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 commence of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in patient management will be evaluated by the following parameters:Patient level diagnosis of SB Crohn's by each modality (i.e. CE, SBFT, ileo-colonoscopy) will be categorized as: [ Time Frame: four months from commence of enrollment ] [ Designated as safety issue: No ]
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 commence of 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 commence of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	155
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Pillcam Platform with RAPID5 software and supporting SB2 capsules

Detailed Description:

Capsule endoscopy has sparked renewed interest in the investigation of inflammatory bowel disease and Crohns disease of the small bowel. A PillCam™ SB2 capsule (Given Imaging Ltd, Yoqneam, Israel) is an indigestible, disposable video camera that transmits high quality images of the small intestinal mucosa. This enables the small intestine to be viewed by physicians investigating for the presence of small bowel disorders which in the past was inaccessible to physicians. This study is designed to determine the clinical impact of Capsule Endoscopy in detecting suspected inflammatory bowel disease and suspected Crohns Disease of the small bowel when compared to standard diagnostic testing.

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

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
Service de Gastroentérologie, Hôpital Sainte-Justine
Montréal, Quebec, Canada, H3T 1C5
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

Responsible Party:	Given Imaging Ltd. ( Corporate Director Clinical Affairs )
Study ID Numbers:	MA-51
Study First Received:	June 14, 2007
Last Updated:	August 2, 2009
ClinicalTrials.gov Identifier:	NCT00487396 History of Changes
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:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010