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A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Aims: * To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD). * To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing. * To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy. * To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy. Project design: Cross sectional, prospective, comparative study Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy on the same day after undergoing bowel preparation. The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day. Professor Macrae and the scholarly selective student researcher will assess the recorded images obtained from capsule colonoscopies once the images have been deidentified. To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD). The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Royal Melbourne Hospital
Parkville, Victoria, Australia
Start Date
February 6, 2015
Primary Completion Date
December 31, 2020
Completion Date
May 5, 2022
Last Updated
November 23, 2022
47
ACTUAL participants
PillCam® COLON 2 Capsule Endoscopy
DEVICE
Lead Sponsor
Melbourne Health
Collaborators
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT06918808