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

NCT01372878 | Completed Results

• 1 other identifier: MA-204
• Study Type: interventional
• Target: 884
• Locations: 2 countries
• Sites: 17

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.

Conditions

CRC Screening

Keywords

Polyps; Capsule endoscopy; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  1 year, same as study duration

Secondary Outcomes (1)

• 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

Interventions

PillCam® COLON 2 procedure DEVICE

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.

Colonoscopy PROCEDURE

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.

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 50 - 75 years of age, and is classified as average risk per the AGA Guidelines on CRC Screening.
• Subject received an explanation about the nature of the study and agrees to provide written informed consent.

You may not qualify if:

• Subject has a history of colorectal cancer
• Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.)
• 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
• 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.
• Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome.
• Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
• Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding, including positive FOBT test of any variety.
• Subject is suspected or diagnosed with bowel obstruction.
• Subject has dysphagia or any swallowing disorder.
• Subject has congestive heart failure.
• Subject has Type 1 or Type II Diabetes.
• 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.
• Subject has a cardiac pacemaker or other implanted electro medical device.
• Subject has any allergy or other known contraindication to the medications used in the study.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (17)

Alabama Digestive Disorders Center P.C.

Huntsville, Alabama, 35802, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Louisville Gastroenterology Associates

Louisville, Kentucky, 40217, United States

Location

Specialists in Gastroenterology

St Louis, Missouri, 63141, United States

Location

Research Associates of New York

New York, New York, 10075, United States

Location

UNC Chapel Hill Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599, United States

Location

Dayton Gstroenterology Inc.

Dayton, Ohio, 45440, United States

Location

Franklin Gastroenterology, PLLC

Franklin, Tennessee, 37067, United States

Location

Gastroenterology Consultants, P.A.

Houston, Texas, 77034, United States

Location

Pasadena Gastroenterology Associates, P.A.

Pasadena, Texas, 77505, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Bikur Holim Hospital

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

The Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

The Chaim Sheba Medical Center at Tel-Hashomer

Tel Litwinsky, Israel

Location

Related Publications (1)

• 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.

  PMID: 25620668 DERIVED

MeSH Terms

Conditions

Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Ravit Peled | Biostatistics and Data Management Manager
• Organization: Given Imaging

ravit.peled@givenimaging.com

+972 (4) 909-7894

Study Officials

• Douglas Rex, Prof.

  Indiana University Hospital, Indianapolis, IN, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2011
• First Posted: June 14, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 1, 2019
• Results First Posted: May 6, 2014

Record last verified: 2012-07

Locations

US (11); IL (6)