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Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01372878
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : May 6, 2014
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Tracking Information
First Submitted Date  ICMJE June 5, 2011
First Posted Date  ICMJE June 14, 2011
Results First Submitted Date  ICMJE April 2, 2014
Results First Posted Date  ICMJE May 6, 2014
Last Update Posted Date August 1, 2019
Study Start Date  ICMJE June 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
Number of subjects with polyps compared to colonoscopy [ 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 where optical colonoscopy is considered as the standard reference.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
  • Number of subjects with polyps compared to colonoscopy [ 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 10 mm where optical colonoscopy is considered as the standard reference.
  • Number of polyps per location compared to colonoscopy [ Time Frame: 1 year, same as study duration ]
    Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting polyps per location (5 segments) equal to or larger than 6 mm where optical colonoscopy is considered as the standard reference.
  • Number of polyps per location compared to colonoscopy [ Time Frame: 1 year, same as study duration ]
    Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting polyps per location (5 segments) equal to or larger than 10 mm where optical colonoscopy is considered as the standard reference.
  • Safety [ Time Frame: Study duration - 1 year ]
    Type, incidence, severity, and duration of adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
Official Title  ICMJE MA-204: Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE CRC Screening
Intervention  ICMJE
  • Device: PillCam® COLON 2 procedure
    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.
  • Procedure: Colonoscopy

    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.

Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2014)
884
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2011)
794
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is between 50 - 75 years of age, and is classified as average risk per the AGA Guidelines on CRC Screening.
  2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion Criteria:

  1. Subject has a history of colorectal cancer
  2. Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.)
  3. 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
  4. 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.
  5. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome.
  6. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
  7. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding, including positive FOBT test of any variety.
  8. Subject is suspected or diagnosed with bowel obstruction.
  9. Subject has dysphagia or any swallowing disorder.
  10. Subject has congestive heart failure.
  11. Subject has Type 1 or Type II Diabetes.
  12. 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.
  13. Subject has a cardiac pacemaker or other implanted electro medical device.
  14. Subject has any allergy or other known contraindication to the medications used in the study.
  15. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  16. 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.
  17. Subject with strictures, fistulas and/or chronic constipation.
  18. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
  19. Subject with known gastrointestinal motility disorders.
  20. Subject has known delayed gastric emptying.
  21. Subject has any condition, which precludes compliance with study and/or device instructions.
  22. 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.
  23. Subject suffers from life threatening conditions.
  24. Concurrent participation in another clinical trial using any investigational drug or device.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01372878
Other Study ID Numbers  ICMJE MA-204
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic - MITG
Study Sponsor  ICMJE Medtronic - MITG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Rex, Prof. Indiana University Hospital, Indianapolis, IN, USA
PRS Account Medtronic - MITG
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP