Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identificatio… (NCT02754661) | Clinical Trial Compass
CompletedNot Applicable
Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.
United States320 participantsStarted 2016-09
Plain-language summary
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.
Who can participate
Age range50 Years – 75 Years
SexALL
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Inclusion criteria
âś“. Subject is between 50 and 75 years of age (for African Americans only, subject is between 45-75 years of age).
âś“. Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.
âś“. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Exclusion criteria
âś•. Subject with history of colorectal cancer or adenoma (including those identified by computed tomography \[CT\], optical colonoscopy \[OC\[, sigmoidoscopy, etc.).
âś•. Subject with history of negative colonoscopy within 10 years, as these subjects would be defined as not requiring screening in this timeframe. For subjects with alternative screening methods, refer to applicable guidelines.
âś•. Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.
âś•. Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
âś•. Subject with current dysphagia or any swallowing disorder.
âś•. Subject with current serious medical conditions that would increase the risk associated with CCE, CTC, or colonoscopy that are so severe that screening would have no benefit.
What they're measuring
1
Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy