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Completed

NCT Number: NCT02469103

The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

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.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C2

Device

C2 and colonoscopy will be performed one after another on the same day

colonoscopy

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2015
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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