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:
NCT01269372
First received: November 18, 2010
Last updated: December 2, 2013
Last verified: December 2013

November 18, 2010
December 2, 2013
December 2010
July 2011   (final data collection date for primary outcome measure)
To evaluate accuracy parameters (sensitivity and specificity) of the Given PillCam® Platform with the PillCam® Colon 2 Capsule compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
# of subjects with polyps equal to or larger than 6mm as detected by CE versus colonocopy
To evaluate accuracy parameters (sensitivity and specificity) of the Given PillCam® Platform with the PillCam® Colon 2 Capsule compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Sensitivity and specificity
Complete list of historical versions of study NCT01269372 on ClinicalTrials.gov Archive Site
  • To evaluate the administrative feasibility and data management of study design. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • To evaluate accuracy parameters (sensitivity and specificity) of the Given PillCam® Platform with the PillCam® Colon 2 Capsule compared to standard Colonoscopy in detecting subjects with polyps equal to or larger than 10 mm [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • To evaluate accuracy parameters (sensitivity and specificity) of the PillCam® Platform with the PillCam® Colon 2 Capsule compared to standard colonoscopy in detecting polyps per location (5 segments) equal to or larger than 6 mm. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • To evaluate accuracy parameters (sensitivity and specificity) of the PillCam® Platform with the PillCam® Colon 2 Capsule compared to standard colonoscopy in detecting polyps per location (5 segments) equal to or larger than 10 mm. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • To evaluate the safety of the Given PillCam® Platform with the PillCam® Colon 2 Capsule procedure [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy.

This study will also use to evaluate the administrative feasibility and data management of study design.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Colorectal Lesions
  • Device: PillCam Colon 2

    Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE).

    Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.

  • Device: Colonoscopy
    The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is between 50 - 75 years of age, and an appropriate candidate for polyp 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, colonoscopy, sigmoidoscopy etc.),
  3. Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) < 5 years.
  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.
  6. Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer.
  7. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
  8. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety
  9. Subject is suspected or diagnosed with bowel obstruction.
  10. Subject has dysphagia or any swallowing disorder.
  11. Subject has congestive heart failure.
  12. Subject has Diabetes.
  13. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months or other uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
  14. Subject has a cardiac pacemaker or other implanted electro medical device.
  15. Subject has any allergy or other known contraindication to the medications used in the study.
  16. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  17. 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.
  18. Subject with strictures, fistulas and/or chronic constipation.
  19. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
  20. Subject with known gastrointestinal motility disorders.
  21. Subject has known delayed gastric emptying.
  22. Subject has any condition, which precludes compliance with study and/or device instructions.
  23. 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.
  24. Subject suffers from life threatening conditions.
  25. Subject currently participating in another clinical study.
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01269372
MA-203
No
Given Imaging Ltd.
Given Imaging Ltd.
Not Provided
Principal Investigator: Douglas Rex, Prof. Indiana University School of Medicine
Given Imaging Ltd.
December 2013

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