Last updated on July 2017

Evaluation the Efficacy of Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.


Brief description of study

The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of CCE versus CTC in a screening population.

Detailed Study Description

This is a multicenter, prospective, randomized study to evaluate the efficacy of CCE versus CTC in the identification of colonic polyps in a screening population. Subjects will be enrolled at up to 20 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened by the gastroenterology site for study participation at a baseline visit which will also include a blood test for renal function (eGFR), and will be evaluated on the randomized procedure day (CCE versus CTC) and again on the day of both the blinded and unblinded OC procedures. Telephone follow-ups will be conducted 5 - 9 days after the CCE/CTC procedure and 5 - 9 days after the unblinded OC procedure to assess subject well-being and capture any AEs, regardless of relationship to the CCE, CTC, or OC procedures. All CCE RAPID® videos and CTC images will be evaluated by local and central readers. All study analyses will be based on central reader results for both CCE and CTC. Two sets of central readers will be utilized, one set for reading of the CCE RAPID® videos and one set for reading the CTC studies. Both groups of readers will be experts in the reading process for their respective procedures. Readers will provide a report of their findings to the sponsor within 2 weeks of capsule ingestion or CTC procedure in order to allow subjects to return within 5 weeks capsule ingestion or CTC procedure to undergo confirmatory OC. The first OC procedure will be performed with the clinician blinded to the CCE or CTC results. Immediately following this blinded procedure, the clinician will review the CCE or CTC results report provided by the sponsor from the central readers, and a second unblinded OC procedure will be performed if there are discrepancies between the CCE/CTC findings and OC. Colonoscopy must not be performed by the same person who conducts the local CCE reading, or anyone who has reviewed CCE/CTC results for that subject. Bowel preparation regimens for all three procedure types will be standardized across sites.

Clinical Study Identifier: NCT02754661

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Mark Fleisher, MD

Borland-Groover Clinic
Jacksonville, FL United States
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Mukund Venu

Loyola University Medical Center
Chicago, IL United States
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Douglas Rex, MD

Indiana University Hospital
Indianapolis, IN United States
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David Pound, MD

Indianapolis Gastroenterology and Hepatology
Indianapolis, IN United States
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Ira Schmelkin, MD

Baystate Hospital
Springfield, MA United States
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Elijabeth Rajan, MD

Mayo Clinic Rochester
Rochester, MN United States
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Brooks Cash, Dr.

Clinical Research Professionals
Saint Louis, MO United States
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Seth Gross, MD

NYU
New York, NY United States
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Suzanne Lewis, MD

Columbia University
New York, NY United States
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Brian Garvin, MD

Asheville Gastroenterology Associates
Asheville, NC United States
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David Kastenberg, MD

Thomas Jefferson University
Philadelphia, PA United States
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Pramod Malik, MD

Virginia Gastroenterology institute
Suffolk, VA United States
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