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

NCT ID: NCT01372878

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 884 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

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

Conditions

CRC Screening

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Interventions

PillCam® COLON 2 procedure

Subjects will undergo a PillCam® COLON 2 procedure which includes ingestion of the PillCam® COLON 2 capsule. PillCam® COLON 2 is a disposable, ingestible capsule that takes video images throughout the digestive system.

Intervention Type: DEVICE

Colonoscopy

Subjects will undergo standard Colonoscopy procedure 4-6 weeks after PillCam® COLON 2 procedure.

Standard colonoscopy involves placement of a standard endoscope (a thin, flexible plastic tube) into the anus and into the colon, a tiny camera in the endoscope allows the study doctor to see the surface of the colon.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Rex, Prof.

Role: PRINCIPAL_INVESTIGATOR

Indiana University Hospital, Indianapolis, IN, USA

Locations

Alabama Digestive Disorders Center P.C.

Huntsville, Alabama, United States

Indiana University Hospital

Indianapolis, Indiana, United States

Louisville Gastroenterology Associates

Louisville, Kentucky, United States

Specialists in Gastroenterology

St Louis, Missouri, United States

Research Associates of New York

New York, New York, United States

UNC Chapel Hill Gastroenterology and Hepatology

Chapel Hill, North Carolina, United States

Dayton Gstroenterology Inc.

Dayton, Ohio, United States

Franklin Gastroenterology, PLLC

Franklin, Tennessee, United States

Gastroenterology Consultants, P.A.

Houston, Texas, United States

Pasadena Gastroenterology Associates, P.A.

Pasadena, Texas, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Soroka University Medical Center

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Bikur Holim Hospital

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

The Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

The Chaim Sheba Medical Center at Tel-Hashomer

Tel Litwinsky, , Israel

Countries

United States; Israel

References

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.

Reference Type: DERIVED

PMID: 25620668 (View on PubMed)

Other Identifiers

MA-204

Identifier Type: -

Identifier Source: org_study_id