Crohn's DiseaseNCT02624414
Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
A study testing PillCam® COLON 2 Capsule Endoscopy in people with Crohn's Disease, run by Melbourne Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- PillCam® COLON 2 Capsule Endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Feb 2015to 5 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients must not:
- Have known/suspected gastrointestinal obstruction
- Have swallowing disorder
- Have a known oesophageal stricture
- Have severe gastroparesis
- Have dementia
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Crohn's Disease
- Being tested
- PillCam® COLON 2 Capsule Endoscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam® COLON 2 Capsule EndoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Anti TNF induction therapy 6-12 months | Other | 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. Receives: Device: PillCam® COLON 2 Capsule Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy
Measured: 24 months
Levels of Faecal calprotectin
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study start6 Feb 2015
- Primary completion31 Dec 2020
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Finlay Macrae, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624414
- Sponsor's protocol ID
- 2014.214
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2015
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
- ClinicalTrials.gov ID
- NCT02624414
- Acronym / sponsor ID
- 2014.214
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti TNF induction therapy 6-12 months | Other | Device: PillCam® COLON 2 Capsule EndoscopyAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- Have known/suspected gastrointestinal obstruction
- Have swallowing disorder
- Have a known oesophageal stricture
- Have severe gastroparesis
- Have dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PillCam® COLON 2 Capsule Endoscopy | Device | Anti TNF induction therapy 6-12 months |
Primary outcome
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.
Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy
Time frame: 24 months
Levels of Faecal calprotectin
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finlay Macrae principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam® COLON 2 Capsule Endoscopy in people with Crohn's Disease, run by Melbourne Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess bowel cleanness based on the % of mucosal surface visualized by the Capsule colonoscopy (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.