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: August 3, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention
Colorectal Lesions
Device: PillCam Colon 2
Device: Colonoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Official Title: 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:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  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 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.
  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: NCT01269372

Locations
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Douglas Rex, Prof. Indiana University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01269372     History of Changes
Other Study ID Numbers: MA-203
Study First Received: November 18, 2010
Last Updated: August 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
polyps
capsule endoscopy
colonoscopy

ClinicalTrials.gov processed this record on October 23, 2014