Clinical trial NCT01269372: Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
Official title: Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Lesions
Keywords: polyps
capsule endoscopy
colonoscopy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity
timeFrame: Up to 6 weeks
measure: Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity
timeFrame: Up to 6 weeks
measure: Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
Study officials:
affiliation: Indiana University School of Medicine
name: Douglas Rex, Prof.
role: PRINCIPAL_INVESTIGATOR
References: