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

Not Applicable

Completed

• Conditions: CRC Screening

• Registration Number: NCT01372878
• Lead Sponsor: Medtronic - MITG

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-05
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Results First Submitted: 2014-04-02
• Results First Submitted QC: 2014-04-02
• Results First Posted: 2014-05-06
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 884

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (17)

Franklin Gastroenterology, PLLC; 🇺🇸 Franklin, Tennessee, United States

Research Associates of New York; 🇺🇸 New York, New York, United States

Alabama Digestive Disorders Center P.C.; 🇺🇸 Huntsville, Alabama, United States

Specialists in Gastroenterology; 🇺🇸 Saint Louis, Missouri, United States

Gastroenterology Associates of Tidewater; 🇺🇸 Chesapeake, Virginia, United States

Dayton Gstroenterology Inc.; 🇺🇸 Dayton, Ohio, United States

Pasadena Gastroenterology Associates, P.A.; 🇺🇸 Pasadena, Texas, United States

Rabin Medical Center; 🇮🇱 Petach-Tikwa, Israel

The Chaim Sheba Medical Center at Tel-Hashomer; 🇮🇱 Tel Hashomer, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

The Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

Soroka University Medical Center; 🇮🇱 Beer-Sheva, Israel

Bikur Holim Hospital; 🇮🇱 Jerusalem, Israel

UNC Chapel Hill Gastroenterology and Hepatology; 🇺🇸 Chapel Hill, North Carolina, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Louisville Gastroenterology Associates; 🇺🇸 Louisville, Kentucky, United States

Gastroenterology Consultants, P.A.; 🇺🇸 Houston, Texas, United States