CRC ScreeningNCT01372878
Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
A study testing PillCam® COLON 2 procedure and Colonoscopy in people with CRC Screening, run by Medtronic - MITG at 17 sites in 2 countries.
Trial summary
This study was design to establish the effectiveness of PillCam® Platform with the PillCam® COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to optical colonoscopy. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CRC Screening
- What is being tested?
- PillCam® COLON 2 procedure and Colonoscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 884 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jun 2011to Jun 2012
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is between 50 - 75 years of age, and is classified as average risk per the AGA Guidelines on CRC Screening.
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
Who cannot join
- Subject has a history of colorectal cancer
- Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.)
- Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) < 5 years as these subjects would be defined not requiring screening in this time frame
- Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
- Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome.
- Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
Show all 24Show fewer
- Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding, including positive FOBT test of any variety.
- Subject is suspected or diagnosed with bowel obstruction.
- Subject has dysphagia or any swallowing disorder.
- Subject has congestive heart failure.
- Subject has Type 1 or Type II Diabetes.
- Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Subject has a cardiac pacemaker or other implanted electro medical device.
- Subject has any allergy or other known contraindication to the medications used in the study.
- 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 intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
- Subject with strictures, fistulas and/or chronic constipation.
- Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
- Subject with known 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 or nursing 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.
- Concurrent participation in another clinical trial using any investigational drug or device.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States11 sites
UNC Chapel Hill Gastroenterology and Hepatology
Chapel Hill, North Carolina, 27599
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Dayton Gstroenterology Inc.
Dayton, Ohio, 45440
Franklin Gastroenterology, PLLC
Franklin, Tennessee, 37067
Gastroenterology Consultants, P.A.
Houston, Texas, 77034
Alabama Digestive Disorders Center P.C.
Huntsville, Alabama, 35802
Indiana University Hospital
Indianapolis, Indiana, 46202
Louisville Gastroenterology Associates
Louisville, Kentucky, 40217
Research Associates of New York
New York, New York, 10075
Pasadena Gastroenterology Associates, P.A.
Pasadena, Texas, 77505
Specialists in Gastroenterology
St Louis, Missouri, 63141
Israel6 sites
Soroka University Medical Center
Beersheba, 84101
Rambam Medical Center
Haifa, 31096
Bikur Holim Hospital
Jerusalem
Rabin Medical Center
Petah Tikva, 49100
The Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
The Chaim Sheba Medical Center at Tel-Hashomer
Tel HaShomer
About this study
Official title: MA-204: Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
This study was design to establish the effectiveness of PillCam® Platform with the PillCam® COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to optical colonoscopy.
Read the detailed description
This multi-center study was designed to evaluate the safety and effectiveness of PillCam Platform with the PillCam COLON 2 capsule as demonstrated by the identification of subjects with polyps, compared to optical colonoscopy.
884 subjects participated in this study. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps.
Each subject was required to follow a bowel preparation regimen and to undergo capsule endoscopy (CE) followed by optical colonoscopy (OC). The optical colonoscopy procedure was scheduled 4-6 weeks after CE procedure to allow for the central readers reading of the PillCam RAPID video.
The colonoscopist was kept blinded to the CE results
- Conditions
- CRC Screening
- Being tested
- PillCam® COLON 2 procedure, Colonoscopy
- Keywords
- Polyps, Capsule endoscopy, Colonoscopy
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam® COLON 2 procedureDevice
Subjects will undergo a PillCam® COLON 2 procedure which includes ingestion of the PillCam® COLON 2 capsule. PillCam® COLON 2 is a disposable, ingestible capsule that takes video images throughout the digestive system.
ColonoscopyProcedure or surgery
Subjects will undergo standard Colonoscopy procedure 4-6 weeks after PillCam® COLON 2 procedure.
Standard colonoscopy involves placement of a standard endoscope (a thin, flexible plastic tube) into the anus and into the colon, a tiny camera in the endoscope allows the study doctor to see the surface of the colon.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference
Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.
Sensitivity measures the proportion of actual positives which are correctly identified as such.
Specificity measures the proportion of negatives which are correctly identified as such.
positive event defined as patients with polyps ≥6 mm detected by OC procedure.
Measured: 1 year, same as study duration
Secondary outcomes (1)
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference
Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.
Measured: 1 year, same as study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
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 CRC ScreeningStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Rex, Prof., Principal investigator, Indiana University Hospital, Indianapolis, IN, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372878
- Sponsor's protocol ID
- MA-204
- Status last verified
- Jul 2012
- First submitted
- 5 Jun 2011
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rex DK, Adler SN, Aisenberg J, Burch WC Jr, Carretero C, Chowers Y, Fein SA, Fern SE, Fernandez-Urien Sainz I, Fich A, Gal E, Horlander JC Sr, Isaacs KL, Kariv R, Lahat A, Leung WK, Malik PR, Morgan D, Papageorgiou N, Romeo DP, Shah SS, Waterman M. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. 2015 May;148(5):948-957.e2. doi: 10.1053/j.gastro.2015.01.025. Epub 2015 Jan 22.
PubMed 25620668
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
- MA-204: Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
- ClinicalTrials.gov ID
- NCT01372878
- Acronym / sponsor ID
- MA-204
- Conditions
- CRC Screening
- Keywords
- Polyps, Capsule endoscopy, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Posted 6 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was design to establish the effectiveness of PillCam® Platform with the PillCam® COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to optical colonoscopy.
Detailed description
This multi-center study was designed to evaluate the safety and effectiveness of PillCam Platform with the PillCam COLON 2 capsule as demonstrated by the identification of subjects with polyps, compared to optical colonoscopy.
884 subjects participated in this study. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps.
Each subject was required to follow a bowel preparation regimen and to undergo capsule endoscopy (CE) followed by optical colonoscopy (OC). The optical colonoscopy procedure was scheduled 4-6 weeks after CE procedure to allow for the central readers reading of the PillCam RAPID video.
The colonoscopist was kept blinded to the CE results
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is between 50 - 75 years of age, and is classified as average risk per the AGA Guidelines on CRC Screening.
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
Key exclusion criteria (24 listed)
- Subject has a history of colorectal cancer
- Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.)
- Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) < 5 years as these subjects would be defined not requiring screening in this time frame
- Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
- Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome.
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 procedureSubjects will undergo a PillCam® COLON 2 procedure which includes ingestion of the PillCam® COLON 2 capsule. PillCam® COLON 2 is a disposable, ingestible capsule that takes video images throughout the digestive system. | Device | – |
| ColonoscopySubjects will undergo standard Colonoscopy procedure 4-6 weeks after PillCam® COLON 2 procedure. Standard colonoscopy involves placement of a standard endoscope (a thin, flexible plastic tube) into the anus and into the colon, a tiny camera in the endoscope allows the study doctor to see the surface of the colon. | Procedure or surgery | – |
Primary outcome
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference
Time frame: 1 year, same as study duration
Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard. Sensitivity measures the proportion of actual positives which are correctly identified as such. Specificity measures the proportion of negatives which are correctly identified as such. positive event defined as patients with polyps ≥6 mm detected by OC procedure.
1 secondary outcome
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference
Time frame: 1 year, same as study duration
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.
- Derived from this study: PubMed 25620668Rex DK, Adler SN, Aisenberg J, Burch WC Jr, Carretero C, Chowers Y, Fein SA, Fern SE, Fernandez-Urien Sainz I, Fich A, Gal E, Horlander JC Sr, Isaacs KL, Kariv R, Lahat A, Leung WK, Malik PR, Morgan D, Papageorgiou N, Romeo DP, Shah SS, Waterman M. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. 2015 May;148(5):948-957.e2. doi: 10.1053/j.gastro.2015.01.025. Epub 2015 Jan 22.
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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.
Douglas Rex, Prof. principal investigator
Indiana University Hospital, Indianapolis, IN, USA
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam® COLON 2 procedure and Colonoscopy in people with CRC Screening, run by Medtronic - MITG at 17 sites in 2 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 24 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 17 sites in United States, Israel. 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?
Yes. Results are posted in the registry (first posted 6 May 2014). 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?
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference (time frame: 1 year, same as study duration). 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 NCT01372878, 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.