Balloon-Assisted (bat) Colonoscopy Using the Naviaid (tm) G-Eye Detects Significantly More Simulated Polyps in A Colon Model

Purpose: Standard colonoscopy (SC) can have a polyp miss rate up to 31%. The NaviAidTM G-Eye System integrates an inflatable balloon onto the flexible tip of a standard colonoscope, which can be partially inflated upon withdrawal for balloon-assisted (BAT) colonoscopy, straightening colon folds and flexures. The mechanical flattening of haustral folds can improve visualization and stabilization, increasing polyp detection rates (PDR). This study compares the diagnostic yield of BAT colonoscopy vs. SC in the detection of simulated polyps in a colon model. Methods: Gastroenterologists were recruited to identify “simulated” colon polyps in a colon model first using SC followed by BAT colonoscopy using the NaviAidTM G-Eye System at a national meeting. The elastic colon model mimics the flexible structure of haustral folds allowing dynamic response to balloon inflation. The model was shorter than a human colon with a withdrawal time of 2 minutes equivalent to 6 minutes in a human colon. There were 12 simulated polyps: 8 obscured behind folds and 4 nonobscured. Demographics, simulated PDR, withdrawal times, and subjective evaluation of instrument usability were analyzed. Results: Fifty gastroenterologists (45 [90%] male, median age 45 years] participated. The median number of years in practice was 11 year (2-51 years) with an average of 24 colonoscopies per week. The mean ± SD number of simulated polyps detected with SC was 5.3±2.0 polyps (44.2% PDR) as compared to BAT, with which 10.5±1.8 polyps were detected (87.5% PDR), p<0.0001. The significantly higher simulated PDR with BAT vs. SC was notable both with non-obscured polyps 3.6±0.64 (90%) vs. 3.0±0.81 (75%), respectively, and for obscured polyps 7.0±1.45 (88%) vs. 2.3±1.57 (29%), p <0.0001 (Figure 1). The mean withdrawal time with BAT was shorter than with SC, 1 minute and 48 seconds vs. 2 minutes and 16 seconds, respectively. On a scale of 1-5 with 1 representing ‘absolutely disagree' and 5 representing ‘absolutely agree,' mean scores for ‘intuitiveness' of the NaviAidTM G-Eye system, ease of handling, improvement in ability to detect simulated polyps, and improvement in PDR in colonoscopy ranged between 4.5-4.8.Figure 1: Percentage of Polyps Detected by Standard vs. BAT Colonoscopy.Conclusion: Balloon-assisted (BAT) colonoscopy with the NaviAidTM G-Eye system significantly improved simulated polyp detection rate in a colon model. Prospective human clinical studies are in progress. Disclosure - Dr. Hasan- None Dr. Gross- None Dr. Pochapin- Smart Medical, Travel Reimbursement to Israel for device analysis Dr. Kiesslich- None Dr. Gralnek- Smart Medical, Consultand and Advisory Board Member