Colonic DiseasesPhase 3NCT01063231
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
A Phase 3 study testing PillCam™ (Capsule Endoscopy) Colon 2 capsule in people with Colonic Diseases and and Large Bowel Diseases, run by Medtronic - MITG at 8 sites in 7 countries.
Trial summary
Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Diseases, and Large Bowel Diseases
- What is being tested?
- PillCam™ (Capsule Endoscopy) Colon 2 capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Sep 2009to Oct 2010
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between the ages of 18-80
- Subject was referred to colonoscopy for at least one of the following reasons:
- Colorectal cancer screening for age ≥50
- Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits for age ≥50
- Positive findings in the colon (e.g. Polyp ≥10mm)
- Personal history of polyps that were removed at least 3 years ago (3 years and above)
Who cannot join
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Subject has high risk of renal insufficiency associated with the use of sodium phosphate
- Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator
- Subject has any allergy or other known contraindication to the medications used in the study
- 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
Show all 15Show fewer
- Subject has a cardiac pacemaker or other implanted electro medical device.
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, incomplete colonoscopies due to obstructions or NSAID enteropathy,
- Subject with gastrointestinal motility disorders
- Subject has known delayed gastric emptying
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Women who are either pregnant at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
France2 sites
Chef de Service dHepato-Gastro-Enterologie et dAssistance Nutritionnelle CHU Nantes
Nantes, 44093
CHU Nancy
Vandœuvre-lès-Nancy, 54511
Netherlands1 site
Academic Medical Center University of Amsterdam
Amsterdam, 1100
About this study
Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.
Read the detailed description
Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by colonoscopy and radiology testing such as: air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy.
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon. Advantages of the Given® Diagnostic System 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 Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.
The PillCam™ SB capsule (formerly M2A® Capsule) that was cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 1,000,000 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. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. To date, several clinical studies have been conducted with Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.
This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.
- Conditions
- Colonic Diseases, and Large Bowel Diseases
- Being tested
- PillCam™ (Capsule Endoscopy) Colon 2 capsule
- Keywords
- Colonic Diseases, bowel diseases
- Medical subject headings
- Colonic Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam™ (Capsule Endoscopy) Colon 2 capsuleDevice
Medical Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases. Receives: Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps ≥6mm and ≥10 mm as compared to conventional colonoscopy
Measured: within 7 days
Secondary outcomes (6)
Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy
Measured: within 7 days
Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy
Measured: within 7 days
Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos
Measured: within 7 days
Capsule transit time within stomach, small bowel and colon based on Rapid videos
Measured: within 7 days
Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy
Measured: Within 7 days
RAPID reading time Number, type and severity of adverse events
Measured: with in 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guido Costamagna, Prof., Principal investigator, Ospedale GemelliGuido Costamagna, Prof, Principal investigator, Ospedale Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063231
- Sponsor's protocol ID
- MA-201
- Status last verified
- Nov 2010
- First submitted
- 18 Oct 2009
- 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 PillCam™ Colon 2 in Visualization of the Colon
- ClinicalTrials.gov ID
- NCT01063231
- Acronym / sponsor ID
- MA-201
- Conditions
- Colonic Diseases, and Large Bowel Diseases
- Keywords
- Colonic Diseases, bowel diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Feb 2010 (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.
Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.
Detailed description
Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by colonoscopy and radiology testing such as: air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy.
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon. Advantages of the Given® Diagnostic System 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 Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.
The PillCam™ SB capsule (formerly M2A® Capsule) that was cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 1,000,000 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. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. To date, several clinical studies have been conducted with Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.
This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: PillCam™ (Capsule Endoscopy) Colon 2 capsuleSubjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is between the ages of 18-80
- Subject was referred to colonoscopy for at least one of the following reasons:
Key exclusion criteria (15 listed)
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Subject has high risk of renal insufficiency associated with the use of sodium phosphate
- Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator
- Subject has any allergy or other known contraindication to the medications used in the study
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™ (Capsule Endoscopy) Colon 2 capsuleMedical Device | Device | 1 |
Primary outcome
Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps ≥6mm and ≥10 mm as compared to conventional colonoscopy
Time frame: within 7 days
6 secondary outcomes
Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy
Time frame: within 7 days
Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy
Time frame: within 7 days
Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos
Time frame: within 7 days
Capsule transit time within stomach, small bowel and colon based on Rapid videos
Time frame: within 7 days
Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy
Time frame: Within 7 days
RAPID reading time Number, type and severity of adverse events
Time frame: with in 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.
Guido Costamagna, Prof. principal investigator
Ospedale Gemelli
Guido Costamagna, Prof principal investigator
Ospedale Gemelli
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PillCam™ (Capsule Endoscopy) Colon 2 capsule in people with Colonic Diseases and and Large Bowel Diseases, run by Medtronic - MITG at 8 sites in 7 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 6 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 8 sites in France, Belgium, Germany, Italy, Netherlands and 2 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps ≥6mm and ≥10 mm as compared to conventional colonoscopy (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; AzTrials last refreshed its copy on 7 Nov 2026.