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Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capsule Endoscopy
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring capsule endoscopy in small bowel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: English speaking adult patients (>18 years old) with known Crohn's disease Exclusion Criteria: Severe medical or psychiatric co-morbidities Active swallowing problems Bowel obstruction History of stricture or fistula Pregnancy Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy Inability to consent Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease

Sites / Locations

  • University of Rochester Medical Center

Outcomes

Primary Outcome Measures

Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease

Secondary Outcome Measures

Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease

Full Information

First Posted
September 13, 2005
Last Updated
September 16, 2015
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00178438
Brief Title
Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
Official Title
A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.
Detailed Description
Wireless capsule endoscopy (CE) is a Food and Drug Administration (FDA) approved technology that allows viewing of the entire small-bowel. Capsule endoscopy involves swallowing a pill-sized camera that sends images to a data recorder worn on a vest. Because Crohn's disease (CD) often involves the small bowel, we would like to find out if capsule endoscopy is useful in diagnosing small-bowel Crohn's disease. Current methods for diagnosing small-bowel Crohn's disease include colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy (ENT), single contrast barium small-bowel follow through (SBFT), and double contrast small-bowel enteroclysis (SBE), but these tests are unable to identify the presence or extent of small-bowel disease in many patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
capsule endoscopy in small bowel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Capsule Endoscopy
Primary Outcome Measure Information:
Title
Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease
Secondary Outcome Measure Information:
Title
Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking adult patients (>18 years old) with known Crohn's disease Exclusion Criteria: Severe medical or psychiatric co-morbidities Active swallowing problems Bowel obstruction History of stricture or fistula Pregnancy Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy Inability to consent Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parvez S Mantry, MD
Organizational Affiliation
University of Rochester Medical Center, Digestive and Liver Disease Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

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