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<p>Despite advances in gastrointestinal endoscopy, the core mechanical principle remains unchanged. This single-center, single-blind, randomized controlled non-inferiority trial compared a novel motorized endoscope (ME) with a conventional endoscope (CE) in 178 adults undergoing screening esophagogastroduodenoscopy. Participants were randomized 1:1 and blinded by pre-procedure sedation. 78 patients received ME and 84 received CE procedures. ME was non-inferior to CE in the primary outcome of total operability score (no biopsy: 95% CI − 1.77 to 0.59, margin − 3; biopsy: − 2.65 to 1.39, margin − 4) and significantly reduced physical fatigue (1.35 ± 0.48 vs. 1.63 ± 0.62; <i>p</i> = 0.002) and improved lens cleanliness (1.83 ± 0.59 vs. 2.17 ± 0.87; <i>p</i> = 0.004) in individual operability items, while lowering physical demand (1.39 ± 0.49 vs. 1.67 ± 0.63; <i>p</i> = 0.002) in NASA-TLX score. CE achieved superior image quality in overall assessment, view, and resolution (all <i>p</i> &lt; 0.05). Patient satisfaction and safety were comparable. ME provided ergonomic benefits without compromising safety or patient experience, achieving non-inferior operability.</p><p><i>Trial registration</i>. Clinical Research Information Service (CRIS), TRN: KCT0010918, Registration date: 19/08/2025.</p>

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Evaluation of a new motorized endoscope versus conventional endoscopy: a single-center, single-blind, randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2025年12月4日

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  • Seoyeon Lee,
  • Gihong Park,
  • Mi Jin Oh,
  • Ji Kon Ryu,
  • Hyunsoo Chung

摘要

Despite advances in gastrointestinal endoscopy, the core mechanical principle remains unchanged. This single-center, single-blind, randomized controlled non-inferiority trial compared a novel motorized endoscope (ME) with a conventional endoscope (CE) in 178 adults undergoing screening esophagogastroduodenoscopy. Participants were randomized 1:1 and blinded by pre-procedure sedation. 78 patients received ME and 84 received CE procedures. ME was non-inferior to CE in the primary outcome of total operability score (no biopsy: 95% CI − 1.77 to 0.59, margin − 3; biopsy: − 2.65 to 1.39, margin − 4) and significantly reduced physical fatigue (1.35 ± 0.48 vs. 1.63 ± 0.62; p = 0.002) and improved lens cleanliness (1.83 ± 0.59 vs. 2.17 ± 0.87; p = 0.004) in individual operability items, while lowering physical demand (1.39 ± 0.49 vs. 1.67 ± 0.63; p = 0.002) in NASA-TLX score. CE achieved superior image quality in overall assessment, view, and resolution (all p < 0.05). Patient satisfaction and safety were comparable. ME provided ergonomic benefits without compromising safety or patient experience, achieving non-inferior operability.

Trial registration. Clinical Research Information Service (CRIS), TRN: KCT0010918, Registration date: 19/08/2025.