Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02469103
Other study ID # UC-C2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Completed NCT03494764 - Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares Phase 2
Recruiting NCT03937609 - TITRATE (inducTIon for acuTe ulceRATivE Colitis) Phase 4
Completed NCT00503243 - Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis Phase 3
Completed NCT03606499 - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Completed NCT02537210 - Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis N/A
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT00488631 - An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT00928681 - A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis Phase 1
Recruiting NCT05242484 - A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2
Completed NCT01036022 - Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis Phase 2
Recruiting NCT03841045 - Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
Active, not recruiting NCT05528510 - A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT02825914 - CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) N/A
Recruiting NCT06049017 - A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2
Completed NCT04567628 - Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
Withdrawn NCT05999708 - A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants Phase 1
Recruiting NCT05611671 - A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Phase 2
Active, not recruiting NCT03596645 - A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03648541 - BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis Phase 2