The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02469103

Enrollment

150

Registered

2015-06-11

Start date

2014-10-31

Completion date

2018-01-31

Last updated

2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative

Keywords

capsule colonoscopy, ulcerative colitis

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.

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.

Interventions

DEVICEC2

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

PROCEDUREcolonoscopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with extent and severity of colonic inflammation	1 day	extent and severity of mucosal inflammation will be assessed by each investigation

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026