The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography (CTC) in a screening population.
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 Adverse Events (AEs), regardless of relationship to the CCE, CTC, or Optical colonoscopy (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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
320
University of South Alabama
Mobile, Alabama, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Loyola University Medical Center
Chicago, Illinois, United States
Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy
Proportion of subjects shown to have an actionable lesion, defined as any polyp or mass lesion ≥6 mm. Diagnostic yield of CCE/CTC will be calculated in relation to the confirmatory Optical colonoscopy results
Time frame: 5-6 weeks from randomized procedure
Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm
Sensitivity (the percentage of patients with disease who test positive) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis
Time frame: 5-6 weeks from randomized procedure
Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm
Specificity (the percentage of patients without disease who test negative) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis
Time frame: 5-6 weeks from randomized procedure
Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
Predictive value of a positive test (PPV) is the percentage of patients with positive tests who have disease assessed in relation to the confirmatory OC results on a "per subject" basis
Time frame: 5-6 weeks from randomized procedure
Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm
Predictive value of a negative test (NPV) is the percentage of patients with negative tests who do not have disease, assessed in relation to the confirmatory OC results on a "per subject" basis.
Time frame: 5-6 weeks from randomized procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indiana University Hospital
Indianapolis, Indiana, United States
Indianapolis Gastroenterology and Hepatology
Indianapolis, Indiana, United States
Baystate Hospital
Springfield, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Clinical Research Professionals
St Louis, Missouri, United States
NYU
New York, New York, United States
Columbia University
New York, New York, United States
...and 3 more locations