The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C2 & colonoscopy

C2 and colonoscopy

Group Type EXPERIMENTAL

C2

Intervention Type DEVICE

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

colonoscopy

Intervention Type PROCEDURE

Interventions

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C2

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

Intervention Type DEVICE

colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No