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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02624414




Registration number
NCT02624414
Ethics application status
Date submitted
25/11/2015
Date registered
8/12/2015
Date last updated
28/08/2019

Titles & IDs
Public title
Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Scientific title
A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Secondary ID [1] 0 0
2014.214
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PillCam® COLON 2 Capsule Endoscopy

Other: Anti TNF induction therapy 6-12 months - All subjects will be identified through The Royal Melbourne Hospital's IBD clinic, associated specialty clinics and the colonoscopy waiting list of The Royal Melbourne Hospital. The potential participants who have been commenced on Anti TNF induction therapy 6-12 months prior to commencement of the study will be identified. The potential participants identified in this way will be informed of the project at the time of contact and assessment; in some instances the potential participant will be informed of the project via telephone where subjects are remote. The potential participants will be provided an Ethically-approved information sheet at this time. Consent will be gained at the time of assessment.


Treatment: Devices: PillCam® COLON 2 Capsule Endoscopy


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess bowel cleanness based on the % of mucosal surface visualized by the Capsule colonoscopy - The quality of bowel preparation will be assessed using a new grading system proposed by Segal, et al, University of Melbourne Honours thesis in preparation, 2014. The investigator will assess five colonic segments (cecum, ascending, transverse and descending colon and the rectum). The investigator will assess bowel cleanness based on the % of mucosal surface visualized by the capsule for the presence of: Faecal residue, Turbid Fluid, Bubbles , Faecal residue on Dome, Rapid movement , Poor lighting, Light reflection.
Each segment will be given a number out of 4: 0 =not present and 4=significantly prevented mucosal visualization.
SES-CD= sum of the above 4 variables for 5 bowel segments (rectum, sigmoid and ascending colon, transverse colon, descending colon and ileum.
The images taken during this procedure will be recorded and analysed at a later date.
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Levels of Faecal calprotectin
Timepoint [3] 0 0
24 months

Eligibility
Key inclusion criteria
- Adults with established diagnosis of CD with ileal, colonic or ileo-colonic disease
aged 18-75 years. Gender: both male and female

- Patients of RMH IBD clinic and other specialty clinics where assessment of mucosal
healing is clinically indicated this includes: Patients who have had Anti TNF
induction therapy 6-12 months prior to commencement of this study AND/OR Patients
referred for colonoscopy to assess mucosal disease status with a view to treatment
escalation based on the findings.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients must not:

- Have known/suspected gastrointestinal obstruction

- Have swallowing disorder

- Have a known oesophageal stricture

- Have severe gastroparesis

- Have dementia

- Have a cardiac pacemaker or other implanted medical device

- Have sever cardiac or renal insufficiency

- Have a previous allergy or contraindication to bowel preparation

- Be pregnant

- Prior major abdominal surgery

- Colonoscopy is contraindicated

Study design
Purpose of the study
Supportive Care
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02624414
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Finlay Macrae
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Finlay Macrae
Address 0 0
Country 0 0
Phone 0 0
+61393427580
Fax 0 0
Email 0 0
finlay.macrae@mh.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02624414