Evaluation of safety, efficacy, and ease of use for screening and surveillance colonoscopy by using a single-use colonoscope with wide-angle field of view

Background and aims: Colonoscopy is the criterion standard for colorectal cancer screening, but missed lesions may lead to interval cancers. This study aimed to demonstrate the safety and effectiveness of a novel single-use colonoscope with an extended 200° field of view, enabling view behind colonic folds and limiting concerns related to reprocessing of devices. Methods: Patients indicated for colonoscopy underwent the procedure with the single-use colonoscope. Detected lesions were resected and analyzed. The main performance endpoint was cecal intubation. The main safety endpoints were absence of serious adverse events or serious adverse device effects. Secondary endpoints included documentation of adenoma and polyp detection rates and other colonoscopy performance metrics. During an initial physician training phase, perceived proficiency and ease of use were evaluated with a Likert scale. Results: A total of 79 participants were recruited. The initial 18 patients constituted the training cohort and 61 patients the study cohort. Cecal intubation with the single-use device was achieved in all 79 patients (95% 2-sided exact Clopper-Pearson confidence interval: 95.4%-100%). There were no serious adverse events or serious adverse device effects. Physician rating of ease of use was very high, and physician proficiency was achieved rapidly. A total of 54 lesions were detected and resected. The adenoma detection rate was 31%. The mean net procedure duration was 16:44 ± 7:32 minutes, and the insertion time was 8:07 ± 5:38 minutes. Conclusion: The use of this single-use colonoscope system with a 200° field of view was effective, safe, and simple. The extended visualization holds potential for greater detection.