S298 Artificial Intelligence (CAD-E)-Assisted Colonoscopy Helps Increase Adenoma Detection Rate (ADR) in the Afternoon Session

Introduction: The aim of the study was to evaluate the clinical benefit and safety of using a computer-aided detection (CADe) device, the Argus® system, for screening, surveillance and diagnostic colonoscopy procedures Methods: A sponsor-initiated, non-blinded, observational prospective randomized controlled study of the Argus® system, a computer-aided diagnostic (CADe) platform, was conducted in the United States to evaluate the safety and efficacy of this device. The study was conducted between May 2 and December 22 of 2022 and was approved by IRB (protocol number 20220415 and document number Argus-01). The study design involved 2 arms in which adult patients undergoing screening, surveillance or diagnostic colonoscopy procedures were randomized to either an AI-aided study arm (standard colonoscopy with the use of the Argus system, AC) or the control arm (colonoscopy without the use of the Argus® system, NAC). During this study, in one of the exploratory endpoints, we compared the ADR between the 2 cohorts for procedures performed in the morning hours and afternoon hours (Figure 1). Results: A total of 686 patients in the modified Intention to Treat (mITT) study cohort were included for primary analysis (n=344 AC; n=342 NAC, Table 1). We noted a significant change between the ADR in the 2 groups in the morning and afternoon sessions (Table 1). In the Control (NAC) grou P- ADR in morning (from 7am to 11am) was 0.41 and in the afternoon (from 11am to 3pm) was 0.33 (a relative percentage difference of 21.62%). In the Argus (CADe) study (AC) grou P- the ADR in morning (from 7am to 11am) was 0.40 and in the afternoon (from 11am to 3pm) was 0.44. The ADR of control (NAC) and CADe -Argus (AC) group in the morning session, were similar (0.40 and 0.41 respectively). The ADR of the 2 groups in the afternoon sessions, however, revealed a 0.12 difference with the Argus (AC) group being higher than the control (NAC) group with a relative percentage difference of 29.2% (P=0.058). We believe that the P-value would reach < 0.05 with a larger cohort. Conclusion: Multiple studies have identified a drop in the ADR in afternoon colonoscopies compared with morning colonoscopies. The reasons proposed for this decrease in ADR are varied including endoscopist’s fatigue and inadequate bowel preparation. In this study, we demonstrate that CADe (Argus) assisted colonoscopy can improve ADR in afternoon colonoscopies and consequently has the potential to be an important adjunct to maintain high quality colonoscopy throughout the day.Figure 1.: ADR from 7 AM to 11 AM and from 11.01 AM to 3 PM. Table 1. - Demographics Information and Exploratory Endpoints Results for mlTT Population (ADR by Time of the Day) Control (N=342) AI (N=344) P-value Sex Male 164 48.0% 148 43.0% 0.1948 Female 178 52.0% 196 57.0% Age-Continuous Mean 62.9 63 0.8627 SD 9.2 9.9 Age-Categorical 40-50 years 22 6.4% 28 8.1% 0.6407 50-65 years 171 50.0% 164 47.7% >65 years 149 43.6% 152 44.2 Race 0.2578 Other Races 1 0.3% 1 0.3% N/A 15 4.4% 9 2.6% Asian 2 0.6% 2 0.6% White 311 90.9% 308 89.5% Black/African American 13 3.8% 24 7.0% Ethnicity 0.1663 Declined 0 0.0% 1 0.3% N/A 21 6.1% 11 3.2% Hispanic/Latino 3 0.9 2 0.6% Non Hispanic/Latino 318 93% 330 95.9% Adenoma Detection Rate (ADR) by time of the day ADR before 11 AM 0.41 0.4 0.913 Difference (AI-Control) −0.01 Adenoma Detected 94 80 Total Procedures 232 200 ADR after 11 AM 0.33 0.44 0.0582 Difference (AI-Control) 0.12 Adenoma Detected 36 64 Total Procedures 110 144