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Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02624414
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Melbourne Health

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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Device: PillCam® COLON 2 Capsule Endoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Actual Study Start Date : February 6, 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: PillCam® COLON 2 Capsule Endoscopy



Primary Outcome Measures :
  1. Assess bowel cleanness based on the % of mucosal surface visualized by the Capsule colonoscopy [ Time Frame: 24 months ]

    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.


  2. Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy [ Time Frame: 24 months ]
  3. Levels of Faecal calprotectin [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624414


Contacts
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Contact: Finlay Macrae +61393427580 finlay.macrae@mh.org.au
Contact: Zafirah Khan +61393427798 zafirah.khan@mh.org.au

Locations
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Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Finlay Macrae    +61393427580    finlay.macrae@mh.org.au   
Contact: Zafirah Khan    +61393427798    zafirah.khan@mh.org.au   
Principal Investigator: Finlay Macrae         
Sponsors and Collaborators
Melbourne Health
Medtronic
Investigators
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Principal Investigator: Finlay Macrae Melbourne Health
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Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT02624414    
Other Study ID Numbers: 2014.214
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases