Colonic DiseaseNCT00604422
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis
An observational study of Colonic Disease and Ulcerative Colitis, run by Medtronic - MITG at 3 sites in 3 countries.
Trial summary
To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonic Disease, Ulcerative Colitis
- How many people
- 97 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2007to Mar 2010
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease The study population will consist of subjects who fulfill all the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Subjects 18-70
- Suspected or known ulcerative colitis patients
Who cannot join
- Subject has dysphagia
- Subject has congestive heart failure
- Subject who can not tolerate bowel preparation
- Poor bowel preparation
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
Show all 15Show fewer
- Subject has a cardiac pacemaker or other implanted electro-medical devices.
- Subject is pregnant
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Subject suffers from life threatening conditions
- Subject is currently participating in another clinical study
- Subject has constipation (less than 3 bowel movements/week)
- Subject has known slow gastric emptying time
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Hong Kong1 site
Chinese university of Hong Kong, Princes of Walses Hospital
Hong Kong
Singapore1 site
Department of Medicine, National University Hospital
Singapore, 119074
Taiwan1 site
Department of Internal Medicine & Health Management Center, National Taiwan University Hospital
Taipei
About this study
To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis
Read the detailed description
Ulcerative colitis (UC) is a disorder of unknown origin that may be characterized by acute and chronic inflammation of the colon. The extent of the colonic mucosal inflammation varies among individuals, but the disease almost always involves the rectum. Ulcerative colitis has required evaluation by colonoscopy to determine the extent and severity of the disease. The PillCam platform offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the PillCam platform include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the PillCam platform may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon.
The PillCam® SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 700,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. Further details of the PillCam® Colon Capsule Endoscope (PCCE) can be found in the device description section.
In previous studies, the PillCam colon platform has been shown to be safe and to be able to demonstrate colon polyps and cancers. This study is an extension to a trial evaluating the use of PCCE in ulcerative colitis that has already been completed in Hong Kong (n=40). This study is designed to assess the ability of the capsule to accurately detect inflammatory lesions and thus classifying the extent and severity of disease in subjects with ulcerative colitis in comparison to traditional colonoscopy.
- Conditions
- Colonic Disease, Ulcerative Colitis
- Keywords
- Colonic disease, Ulcerative colitis, suspected or known colonic disease
- Medical subject headings
- Colonic Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement level between capsule and colonoscopy in classifying colitis into the above (see section 3.1) categories.
Measured: within 7 days
Secondary outcomes (7)
Number, type and severity of adverse events with both PCCE and standard colonoscopy
Measured: Within 7 days
Accuracy parameters for detecting active UC
Measured: within 7 days
Disease severity scoring index for both PCCE and .standard colonoscopy
Measured: within 7 days
Colon cleansing level score for both PCCE and standard colonoscopy.
Measured: within 7 days
Grading of the bubbles interference at the colon for PCCE.
Measured: Within 7 days
Percentage of excreted colon capsules
Measured: Within 7 Days
PCCE transit time from ingestion to excretion and colon transit time
Measured: Within 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josef Sung, Prof., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604422
- Sponsor's protocol ID
- MA-107
- Status last verified
- Mar 2010
- First submitted
- 24 Jan 2008
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00604422
- Acronym / sponsor ID
- MA-107
- Conditions
- Colonic Disease, Ulcerative Colitis
- Keywords
- Colonic disease, Ulcerative colitis, suspected or known colonic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Jan 2008 (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.
To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis
Detailed description
Ulcerative colitis (UC) is a disorder of unknown origin that may be characterized by acute and chronic inflammation of the colon. The extent of the colonic mucosal inflammation varies among individuals, but the disease almost always involves the rectum. Ulcerative colitis has required evaluation by colonoscopy to determine the extent and severity of the disease. The PillCam platform offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the PillCam platform include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the PillCam platform may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon.
The PillCam® SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 700,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. Further details of the PillCam® Colon Capsule Endoscope (PCCE) can be found in the device description section.
In previous studies, the PillCam colon platform has been shown to be safe and to be able to demonstrate colon polyps and cancers. This study is an extension to a trial evaluating the use of PCCE in ulcerative colitis that has already been completed in Hong Kong (n=40). This study is designed to assess the ability of the capsule to accurately detect inflammatory lesions and thus classifying the extent and severity of disease in subjects with ulcerative colitis in comparison to traditional colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease The study population will consist of subjects who fulfill all the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (2 listed)
- Subjects 18-70
- Suspected or known ulcerative colitis patients
Key exclusion criteria (15 listed)
- Subject has dysphagia
- Subject has congestive heart failure
- Subject who can not tolerate bowel preparation
- Poor bowel preparation
- Subject has renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement level between capsule and colonoscopy in classifying colitis into the above (see section 3.1) categories.
Time frame: within 7 days
7 secondary outcomes
Number, type and severity of adverse events with both PCCE and standard colonoscopy
Time frame: Within 7 days
Accuracy parameters for detecting active UC
Time frame: within 7 days
Disease severity scoring index for both PCCE and .standard colonoscopy
Time frame: within 7 days
Colon cleansing level score for both PCCE and standard colonoscopy.
Time frame: within 7 days
Grading of the bubbles interference at the colon for PCCE.
Time frame: Within 7 days
Percentage of excreted colon capsules
Time frame: Within 7 Days
PCCE transit time from ingestion to excretion and colon transit time
Time frame: Within 7 Days
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 31 Jul 2019.
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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.
Josef Sung, Prof. principal investigator
Chinese University of Hong Kong
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Disease and Ulcerative Colitis, run by Medtronic - MITG at 3 sites in 3 countries.
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 15 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong, Singapore, Taiwan. 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?
Agreement level between capsule and colonoscopy in classifying colitis into the above (see section 3.1) categories. (time frame: within 7 days). 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 31 Jul 2019.