An interventional study of EndoVigilant Software in Colon Polyp, Colon Neoplasm and Colon Adenoma, sponsored by EndoVigilant Inc. Terminated at 4 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by EndoVigilant Inc · Not applicable, Interventional, and Diagnostic
EndoVigilant software device augments existing colonoscopy procedure video in real-time by highlighting colon polyps and mucosal abnormalities. It is intended to assist gastroenterologists in detection of adenomas and serrated polyps. The device is an adjunctive tool and is not intended to replace physicians' decision making related to detection, diagnosis or treatment.
This study with an adaptive design measures the clinical benefit (increase in detection of adenomatous and serrated polyps) and increased risk (increased extraction of non-adenomas) during standard colonoscopy procedures when EndoVigilant software device is used.
This study will analyze the clinical benefit and risk of using the EndoVigilant polyp detection assistance software based device during screening and surveillance colonoscopy procedures. The study subjects will be randomized to a procedure with or without the use of EndoVigilant software. While using this device, colonoscopy will continue to be performed in the standard manner as is done without the use of this device. The video signal from the colonoscope will be fed into a computer running the EndoVigilant software in addition to the standard video output to the procedure monitor. The gastroenterologist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the augmented video on the second monitor. The gastroenterologist may rely on the second monitor (with augmented video generated from EndoVigilant software) for polyp detection, but the standard procedure monitor with the original feed will always be operational and available for maneuvers such as fast insertion, polypectomy etc.
The study will have an adaptive design with an interim analysis after 700 subjects to re-estimate the final sample size of the study.
The study will include a diverse set of endoscopists across age, sex, years of experience and practice settings. In order to comply with FDA guidance this pivotal study will only include endoscopists with ADR of 25-40% in their routine clinical practice. At the discretion of Endovigilant, endoscopists with an ADR of \<25% or >40% may be included for a separate exploratory analysis to examine the impact of the system on endoscopists with ADR outside of the FDA-mandated range. But in accordance with FDA guidance, the procedures done by these endoscopists will not be included in the primary endpoint analysis.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 769 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →EndoVigilant Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Colonoscopy Procedure is performed with EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure.
Device: EndoVigilant Software
Colonoscopy Procedure is performed without EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure.
While using this device, colonoscopy will continue to be performed in the standard manner as is done without the use of this device. The video signal from the colonoscope will be fed into a computer running the EndoVigilant software in addition to the standard video output to the procedure monitor. The gastroenterologist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the augmented video on the second monitor. The gastroenterologist may rely on the second monitor (with augmented video generated from EndoVigilant software) for polyp detection, but the standard procedure monitor with the original feed will always be operational and available for maneuvers such as fast insertion, polypectomy etc.
Average Number of Adenomas Per Colonoscopy
Average Number of Adenomas Per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Average Number of Adenomas Per Extraction
Percent of extractions that are adenomas per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Average Number of Serrated Polyps per Colonoscopy
Average Number of Serrated Polyps per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Average Number of Non-adenomatous, non-serrated polyps per colonoscopy
Average Number of Non-adenomatous, non-serrated polyps per colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Adenoma Detection Rate in Screening Colonoscopies
Adenoma Detection Rate in Screening Colonoscopies for study subjects undergoing screening colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Serrated Polyp Detection Rate in Screening Colonoscopies
Serrated Polyp Detection Rate in Screening Colonoscopies for study subjects undergoing screening colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Adenoma Detection Rate in All Colonoscopies
Adenoma Detection Rate in All Colonoscopies for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Serrated Polyp Detection Rate in All Colonoscopies
Serrated Polyp Detection Rate in All Colonoscopies for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Adenomatous Polyp Location Distribution Per Colonoscopy (Distal and Proximal Colon)
Adenomatous Polyp Location Distribution Per Colonoscopy (Distal and Proximal Colon) for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Adenomatous Polyp Size Distribution Per Colonoscopy <6mm, 6-10mm, or >=10mm)
Adenomatous Polyp Size Distribution Per Colonoscopy \<6mm, 6-10mm, or \>=10mm) for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Adenomatous Polyp Distribution by Paris Classification (Ip/Is, IIa/b/c) Per Colonoscopy
Adenomatous Polyp Distribution by Paris Classification (Ip/Is, IIa/b/c) Per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)
Withdrawal Time
Average time duration from the time when cecum is reached and the end of the colonoscopy procedure for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Completion of the procedure (typically less than an hour)
Procedure Time
Average duration of the entire colonoscopy procedure for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.
Time frame: Completion of the procedure (typically less than an hour)
Plan to share: No
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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