Colonic DiseasesPhase 3MA-53NCT00604162
PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
A Phase 3 study testing PillCam COLON and Standard colonoscopy in people with Colonic Diseases, run by Medtronic - MITG at 7 sites in 5 countries.
Trial summary
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- PillCam COLON and Standard colonoscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject was referred for colonoscopy for one of the following reasons:
- Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
- Any subject ≥ 18 years of age with:
- Positive findings in the colon on a GastroIntestinal (GI) radiographic study
- Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
- Suspected or known ulcerative colitis
Who cannot join
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Chronic use of laxatives
- Subject has a cardiac pacemakers or other implanted electro medical devices.
Show all 14Show fewer
- Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- 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.
- Age < 18 years
- Subject suffers from life threatening conditions
- Subject is currently participating in another clinical study
- Subject has known slow gastric emptying time
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
About this study
Official title: Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
Read the detailed description
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.
This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).
- Conditions
- Colonic Diseases
- Being tested
- PillCam COLON, Standard colonoscopy
- Keywords
- Suspected colonic disease, Known colonic disease
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam COLONDevice
The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.
Standard colonoscopyProcedure or surgery
Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
| Study group | Role | What they receive |
|---|---|---|
| PillCam COLON and Colonoscopy | Experimental | Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy. Receives: Device: PillCam COLON; Procedure: Standard colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies
The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.
Measured: 1 day
Number of Participants With Indicated Lesions Detected by Standard Colonoscopy
Since the standard colonoscopy is the "gold standard" to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger.
Measured: 1 day
Sensitivity of Capsule Endoscopy for Indicated Lesions
Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.
Measured: 1 day
Specificity of Capsule Endoscopy for Indicated Lesions
Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.
Measured: 1 day
Secondary outcomes (5)
Percent of Participants With Scoring Index 3 or 4
Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:
- poor cleansing level (Large amount of fecal residue.)
- fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)
- good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)
- excellent cleansing level (No more than small bits of adherent feces.)
Measured: 1 day
Number, Type and Severity of Adverse Events
Measured: Within 7 days
Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy
Measured: within 7 days
Percentage of Excreted Colon Capsules
Measured: Within 7 days
Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)
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 startOct 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacques DEVIERE, M.D, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604162
- Sponsor's protocol ID
- MA-53
- Acronym
- MA-53
- Status last verified
- Aug 2010
- First submitted
- 24 Jan 2008
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Van Gossum A, Munoz-Navas M, Fernandez-Urien I, Carretero C, Gay G, Delvaux M, Lapalus MG, Ponchon T, Neuhaus H, Philipper M, Costamagna G, Riccioni ME, Spada C, Petruzziello L, Fraser C, Postgate A, Fitzpatrick A, Hagenmuller F, Keuchel M, Schoofs N, Deviere J. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009 Jul 16;361(3):264-70. doi: 10.1056/NEJMoa0806347.
PubMed 19605831
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
- ClinicalTrials.gov ID
- NCT00604162
- Acronym / sponsor ID
- MA-53 / MA-53
- Conditions
- Colonic Diseases
- Keywords
- Suspected colonic disease, Known colonic disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 18 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
Detailed description
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.
This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PillCam COLON and Colonoscopy | Experimental | Device: PillCam COLON, Procedure: Standard colonoscopySubjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject was referred for colonoscopy for one of the following reasons:
Key exclusion criteria (14 listed)
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Chronic use of laxatives
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 COLONThe PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy. | Device | PillCam COLON and Colonoscopy |
| Standard colonoscopyStandard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning. | Procedure or surgery | PillCam COLON and Colonoscopy |
Primary outcome
Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies
Time frame: 1 day
The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.
Number of Participants With Indicated Lesions Detected by Standard Colonoscopy
Time frame: 1 day
Since the standard colonoscopy is the "gold standard" to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger.
Sensitivity of Capsule Endoscopy for Indicated Lesions
Time frame: 1 day
Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.
Specificity of Capsule Endoscopy for Indicated Lesions
Time frame: 1 day
Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.
5 secondary outcomes
Percent of Participants With Scoring Index 3 or 4
Time frame: 1 day
Number, Type and Severity of Adverse Events
Time frame: Within 7 days
Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy
Time frame: within 7 days
Percentage of Excreted Colon Capsules
Time frame: Within 7 days
Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)
Time frame: within 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19605831Van Gossum A, Munoz-Navas M, Fernandez-Urien I, Carretero C, Gay G, Delvaux M, Lapalus MG, Ponchon T, Neuhaus H, Philipper M, Costamagna G, Riccioni ME, Spada C, Petruzziello L, Fraser C, Postgate A, Fitzpatrick A, Hagenmuller F, Keuchel M, Schoofs N, Deviere J. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009 Jul 16;361(3):264-70. doi: 10.1056/NEJMoa0806347.
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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.
Jacques DEVIERE, M.D principal investigator
Erasme University Hospital
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PillCam COLON and Standard colonoscopy in people with Colonic Diseases, run by Medtronic - MITG at 7 sites in 5 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 14 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Germany, Italy, Spain, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00604162, which also lists 1 linked publication.
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 1 Aug 2019.