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CompletedNCT02469103Updated Jul 17, 2018

The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

An interventional study of C2 and colonoscopy in Colitis, Ulcerative, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Oct 2014, registered Jun 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Colitis, Ulcerative

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Keywords

  • capsule colonoscopy
  • ulcerative colitis
03

In context

Colitis, Ulcerative

1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.

This study's enrollment of 150 is above the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    C2 & colonoscopy

    C2 and colonoscopy

    Device: C2 · Procedure: colonoscopy

Interventions

  • DeviceC2

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

  • Procedurecolonoscopy
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What researchers measure

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

    Time frame: 1 day

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Study locations

1 site
  • Prince of Wales Hospital
    Hong Kong, 0000, Hong Kong
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References and documents

Publications

  • 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. PubMed 28713062 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02469103
Responsible party
Siew Chien NG (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jun 11, 2015
Start date
Oct 2014
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Jul 17, 2018

Study contacts

Siew Ng
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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