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The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469103
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Brief Summary:
The purpose of this study is to investigate the accuracy of second generation colon capsule (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using conventional endoscopy as the gold standard.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Device: C2 Procedure: colonoscopy Not Applicable

Detailed Description:
Consecutive patients with ulcerative colitis will be recruited. Second generation colon capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos and those who perform conventional colonosocpies independently. Physicians who review C2 videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos, respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using conventional endoscopy as the gold standard.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
Actual Study Start Date : October 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C2 & colonoscopy
C2 and colonoscopy
Device: C2
C2 and colonoscopy will be performed one after another on the same day

Procedure: colonoscopy



Primary Outcome Measures :
  1. Number of participants with extent and severity of colonic inflammation [ Time Frame: 1 day ]
    extent and severity of mucosal inflammation will be assessed by each investigation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-80 years
  • suspected or known UC
  • written informed consent

Exclusion Criteria:

  • patients with severe UC according to Truelove and Witts' criteria
  • current pregnancy/lactating
  • patients with a pacemaker or other implanted electromedical device
  • the presence of dysphagia
  • patients at higher risk of capsule retention (including Crohn's disease, small bowel tumor, radiation enteropathy, previous intestinal surgery, acute abdominal pain without regular defecation)
  • patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition)
  • patients with an allergy to polyethylene glycol, sodium phosphate solution, metoclopramide or bisacodyl suppository

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469103


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew Ng Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02469103    
Other Study ID Numbers: UC-C2
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
capsule colonoscopy
ulcerative colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases