Randomized Controlled Trial Evaluating the Safety, Efficacy, and Patient Comfort of a Single-Use Electronic Colonoscope.

BACKGROUND AND AIM: Although reusable colonoscopes remain the clinical gold standard, persistent microbial biofilms compromise reprocessing efficacy and increase cross-contamination risk. This study evaluated a novel single-use colonoscope compared to a conventional device across key clinical and patient-centered outcomes.

METHODS

In a single-blind randomized trial, 100 patients (aged 18-80 years) undergoing conscious sedation colonoscopy were assigned (1:1) to a single-use colonoscope (Endofresh XZING-C200B) or a conventional colonoscope (Olympus CF-H260). Primary endpoints included patient comfort (assessed via real-time grip strength dynamometry), therapeutic endoscopic mucosal resection (EMR) efficacy, adenoma detection rate (ADR), adenomas per colonoscopy (APC), and cecal intubation time.

RESULTS

Groups were demographically balanced. No significant differences were observed in patient comfort (p > 0.05), EMR outcomes (100% en bloc resection; median procedure times: 11.32 ± 4.55 vs. 11.57 ± 7.95 min, p = 0.899), diagnostic performance (ADRs: 56% vs. 60%, p = 0.685; APCs median: 1.0 vs. 1.0, p = 0.349), or cecal intubation time (7.47 ± 5.81 vs. 6.13 ± 4.06 min, p = 0.185). One sigmoid colon cancer was detected per group. The single-use device showed inferior image quality and far-field brightness (both p < 0.001).

CONCLUSIONS

In this exploratory randomized trial, the novel single-use colonoscope demonstrated clinical efficacy and safety profiles comparable to the conventional system. These preliminary findings support its potential for integration into routine screening, pending confirmation in larger noninferiority studies. Chinese Clinical Trial Registry: ChiCTR2400082142.