Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease

NCT00487396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2020-10-22

Study results available
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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.

Conditions

Interventions

DEVICE

Capsule Endoscopy

Pillcam Platform with RAPID5 software and supporting SB2 capsules

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Jonathan Leighton, MD · Mayo Clinic

  • Peter Legnani, MD · Private Practice New York, New York

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-10-31
Completion
2010-11-30

Countries

  • United States
  • Canada
  • Israel
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487396 on ClinicalTrials.gov