Back to resultsThe Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
Primary Purpose
Colitis, Ulcerative
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
C2
colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colitis, Ulcerative focused on measuring capsule colonoscopy, ulcerative colitis
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C2 & colonoscopy
Arm Description
C2 and colonoscopy
Outcomes
Primary Outcome Measures
Number of participants with extent and severity of colonic inflammation
extent and severity of mucosal inflammation will be assessed by each investigation
Secondary Outcome Measures
Full Information
NCT ID
NCT02469103
First Posted
June 9, 2015
Last Updated
July 16, 2018
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02469103
Brief Title
The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
Official Title
The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
capsule colonoscopy, ulcerative colitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C2 & colonoscopy
Arm Type
Experimental
Arm Description
C2 and colonoscopy
Intervention Type
Device
Intervention Name(s)
C2
Intervention Description
C2 and colonoscopy will be performed one after another on the same day
Intervention Type
Procedure
Intervention Name(s)
colonoscopy
Primary Outcome Measure Information:
Title
Number of participants with extent and severity of colonic inflammation
Description
extent and severity of mucosal inflammation will be assessed by each investigation
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siew Ng
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28713062
Citation
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.
Results Reference
derived
Learn more about this trial
The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
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