This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
112
CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.
Silicon Valley Research Institute, Inc.
San Jose, California, United States
CapsoVision Research Clinic
Saratoga, California, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
Efficacy Assessments
Determine the Accuracy of CapsoCam® to detect and measure size of colon polyps relative to the colonoscopy procedure.
Time frame: Day 1
Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs)
All adverse events including SAEs/UADEs will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be reported. A serious adverse event is one that meets the definition outlined in Section 8 of this protocol.
Time frame: Day 1-3
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