Clinical Evaluation of PolyDeep, A Computer-Aided Detection System: A Multicenter Randomized Tandem Colonoscopy Trial

Background/Objectives: Computer-aided detection (CADe) systems are increasingly used in endoscopy to enhance lesion recognition. PolyDeep is a CADe/x tool previously assessed in an observational study. The aim of our study is to determine if PolyDeep-assisted colonoscopy reduces the adenoma miss rate (AMR) compared with conventional colonoscopy. Methods: We carried out a multicenter randomized controlled trial with a tandem colonoscopy design in participants from a colorectal cancer screening program (positive fecal immunochemical test-FIT or surveillance). Expert endoscopists performed all colonoscopies, and patients were allocated to groups by a computer-generated sequence. The primary endpoint was AMR; secondary endpoints included polyp miss rate (PMR), serrated lesion miss rate (SLMR) and advanced polyp miss rate (APMR). Results: From May to November 2023, we recruited 260 patients and excluded 20, leaving 240 for analysis. Baseline characteristics were balanced between groups (62.1% male; mean age 62.3 ± 6.5 years; 65.8% FIT-positive; mean first withdrawal time 13:38 ± 08:07 min; mean second withdrawal time 07:50 ± 03:38 min; lesion detection rate 76.6%; mean polyps per patient 3.4 ± 3.1). We did not find statistically significant differences between PolyDeep-assisted and conventional colonoscopy groups in AMR (21.3% vs. 18.1%, p = 0.5), PMR (21.8% vs. 20.3%, p = 0.7), SLMR (23.4% vs. 25.6%, p = 0.9) or APMR (7.3% vs. 11.3%, p = 0.5). In the subgroup analysis according to indication, we did not find any statistically significant differences. Conclusions: In the context of a CRC screening program, PolyDeep-assisted colonoscopy did not reduce AMR.