Indiana University Hospital
Indianapolis, Indiana, 46202, United States
NCT Number: NCT02345889
Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
colonoscopy performed with the FUSE® (full spectrum endoscopy) system
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
Current standard of care colonoscopy
Time frame: During Procedure
Time frame: During Procedure
Time frame: During Procedure
Time frame: During Procedure
Time frame: During Procedure
Number of patients with 1 or more sessile serrated polyps
Time frame: During Procedure
Time frame: During Procedure
Time frame: During Procedure
Time frame: During Procedure
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Time frame: During Procedure
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Time frame: During Procedure
Time frame: During Procedure
Time frame: During Procedure
Indiana University
Other
A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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