Clinical trial NCT01372878: Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
Official title: MA-204: Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CRC Screening
Keywords: Polyps
Capsule endoscopy
Colonoscopy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 884
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: SCREENING

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

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 1 year, same as study duration
Secondary outcomes:
measure: 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
timeFrame: 1 year, same as study duration
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Alabama Digestive Disorders Center P.C.
state: Alabama
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Louisville
country: United States
facility: Louisville Gastroenterology Associates
state: Kentucky
city: Saint Louis
country: United States
facility: Specialists in Gastroenterology
state: Missouri
city: New York
country: United States
facility: Research Associates of New York
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Gastroenterology and Hepatology
state: North Carolina
city: Dayton
country: United States
facility: Dayton Gstroenterology Inc.
state: Ohio
city: Franklin
country: United States
facility: Franklin Gastroenterology, PLLC
state: Tennessee
city: Houston
country: United States
facility: Gastroenterology Consultants, P.A.
state: Texas
city: Pasadena
country: United States
facility: Pasadena Gastroenterology Associates, P.A.
state: Texas
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Bikur Holim Hospital
city: Petach-Tikwa
country: Israel
facility: Rabin Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center at Tel-Hashomer
city: Tel-Aviv
country: Israel
facility: The Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Indiana University Hospital, Indianapolis, IN, USA
name: Douglas Rex, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Adler SN, Aisenberg J, Burch WC Jr, Carretero C, Chowers Y, Fein SA, Fern SE, Fernandez-Urien Sainz I, Fich A, Gal E, Horlander JC Sr, Isaacs KL, Kariv R, Lahat A, Leung WK, Malik PR, Morgan D, Papageorgiou N, Romeo DP, Shah SS, Waterman M. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. 2015 May;148(5):948-957.e2. doi: 10.1053/j.gastro.2015.01.025. Epub 2015 Jan 22.