NCT00487396

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 16, 2012

Completed
Last Updated

October 22, 2020

Status Verified

September 1, 2020

Enrollment Period

3.1 years

First QC Date

June 14, 2007

Results QC Date

March 20, 2012

Last Update Submit

September 30, 2020

Conditions

Crohn's Disease

Keywords

capsule endoscopyCrohn's diseasesmall bowel diseaseinflammatory bowel diseasePatients with suspected small bowel Crohn's disease

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT)

    To evaluate whether capsule endoscopy (CE) prior to ileocolonoscopy (IC) improves the diagnostic yield in patients with suspected Crohn's disease when compared to IC and SBFT. McNemar test was preformed in order to evaluate the diagnostic yield of IC combined with CE as compared to the diagnostic yield of IC combined with SBFT.

    four months from enrollment

Secondary Outcomes (2)

  • Diagnostic Yield (CE vs. SBFT)

    four months from enrollment

  • Diagnostic Yield (CE vs. IC)

    four months from enrollment

Interventions

Capsule EndoscopyDEVICE

Pillcam Platform with RAPID5 software and supporting SB2 capsules

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Mayo Clinic Arizona

Scottsdale, Arizona, 10128, United States

Location

Atlanta Gastroenterology

Atlanta, Georgia, 30342, United States

Location

Stan Cohen

Atlanta, Georgia, 30342, United States

Location

John Hopkins - Department of Medicine

Baltimore, Maryland, 21287, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01612, United States

Location

Minnesota Gastroenterology Associates

Plymouth, Minnesota, 55446, United States

Location

Private Practice

New York, New York, 10128, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Malmo University Hospital UMAS

Malmo, 20502, Sweden

Location

Related Publications (1)

  • Leighton JA, Gralnek IM, Cohen SA, Toth E, Cave DR, Wolf DC, Mullin GE, Ketover SR, Legnani PE, Seidman EG, Crowell MD, Bergwerk AJ, Peled R, Eliakim R. Capsule endoscopy is superior to small-bowel follow-through and equivalent to ileocolonoscopy in suspected Crohn's disease. Clin Gastroenterol Hepatol. 2014 Apr;12(4):609-15. doi: 10.1016/j.cgh.2013.09.028. Epub 2013 Sep 27.

    PMID: 24075891DERIVED

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Director, Clinical Affairs
Organization
Given Imaging
Hila.Debby@givenimaging.com
+972-4-9097777

Study Officials

  • Jonathan Leighton, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Peter Legnani, MD

    Private Practice New York, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2007

First Posted

June 18, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

October 22, 2020

Results First Posted

May 16, 2012

Record last verified: 2020-09

Locations

IL(1)CA(1)US(8)SE(1)