The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

Official title:

The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469103
• Other study ID #: UC-C2
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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

Procedure:
• colonoscopy

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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