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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01372878
First received: June 5, 2011
Last updated: May 13, 2014
Last verified: July 2012
  Purpose

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.


Condition Intervention
CRC Screening
Device: PillCam® COLON 2 procedure
Procedure: Colonoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: MA-204: Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 884
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372878

Locations
United States, Alabama
Alabama Digestive Disorders Center P.C.
Huntsville, Alabama, United States, 35802
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Louisville Gastroenterology Associates
Louisville, Kentucky, United States, 40217
United States, Missouri
Specialists in Gastroenterology
St. Louis, Missouri, United States, 63141
United States, New York
Research Associates of New York
New York, New York, United States, 10075
United States, North Carolina
UNC Chapel Hill Gastroenterology and Hepatology
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Dayton Gstroenterology Inc.
Dayton, Ohio, United States, 45440
United States, Tennessee
Franklin Gastroenterology, PLLC
Franklin, Tennessee, United States, 37067
United States, Texas
Gastroenterology Consultants, P.A.
Houston, Texas, United States, 77034
Pasadena Gastroenterology Associates, P.A.
Pasadena, Texas, United States, 77505
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Israel
Soroka University Medical Center
Beer-Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 31096
Bikur Holim Hospital
Jerusalem, Israel
Rabin Medical Center
Petach-Tikwa, Israel, 49100
The Chaim Sheba Medical Center at Tel-Hashomer
Tel Hashomer, Israel
The Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Douglas Rex, Prof. Indiana University Hospital, Indianapolis, IN, USA
  More Information

Additional Information:
No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01372878     History of Changes
Other Study ID Numbers: MA-204
Study First Received: June 5, 2011
Results First Received: April 2, 2014
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board
Israel: Ministry of Health

Keywords provided by Given Imaging Ltd.:
Polyps
Capsule endoscopy
Colonoscopy

ClinicalTrials.gov processed this record on October 19, 2014