The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

NCT02469103 | Completed

• 1 other identifier: UC-C2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Ulcerative

Keywords

capsule colonoscopy; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Number of participants with extent and severity of colonic inflammation

  extent and severity of mucosal inflammation will be assessed by each investigation

  1 day

Study Arms (1)

C2 & colonoscopy

EXPERIMENTAL

C2 and colonoscopy

Device: C2; Procedure: colonoscopy

Interventions

C2 DEVICE

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

C2 & colonoscopy

colonoscopy PROCEDURE

C2 & colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

Location

Related Publications (1)

• Shi HY, Chan FKL, Higashimori A, Kyaw M, Ching JYL, Chan HCH, Chan JCH, Chan AWH, Lam KLY, Tang RSY, Wu JCY, Sung JJY, Ng SC. A prospective study on second-generation colon capsule endoscopy to detect mucosal lesions and disease activity in ulcerative colitis (with video). Gastrointest Endosc. 2017 Dec;86(6):1139-1146.e6. doi: 10.1016/j.gie.2017.07.007. Epub 2017 Jul 14.

  PMID: 28713062 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Siew Ng

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: October 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)