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Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers (with videos).

机译:使用遥控胶囊内窥镜检查人的胃:健康志愿者的可行性研究(视频)。

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BACKGROUND: Remote control of capsule endoscopes might allow reliable inspection of the human stomach. OBJECTIVE: To assess the safety and efficacy of manipulation of a modified capsule endoscope with magnetic material (magnetic maneuverable capsule [MMC]) in the human stomach by using a handheld external magnet. DESIGN: Open clinical trial. SETTING: Academic hospital. PATIENTS: Ten healthy volunteers. INTERVENTIONS: Subjects swallowed the MMC and sherbet powder for gastric distention. An external magnetic paddle (EMP-2) was used to manipulate the MMC within the stomach. MMC responsiveness was evaluated on a screen showing the MMC film in real time. MAIN OUTCOME MEASUREMENTS: Safety and tolerability (questionnaire), gastric residence time of the MMC, its responsiveness to the EMP-2, area of gastric mucosa visualized. RESULTS: There were no adverse events. The MMC was always clearly attracted by the EMP-2 and responded to its movements. It remained in the stomach for 39 +/- 24 minutes. In 7 subjects, both the cardia and the pylorus were inspected and 75% or more of the gastric mucosa was visualized (>/=50% in all of the remaining subjects). A learning curve was clearly recognizable (identification of MMC localization, intended movements). LIMITATIONS: Small amounts of fluid blocked the view of apical parts of the fundus; gastric distention was not sufficient to flatten all gastric folds. CONCLUSIONS: Remote control of the MMC in the stomach of healthy volunteers using a handheld magnet is safe and feasible. Responsiveness of the MMC was excellent, and visualization of the gastric mucosa was good, although not yet complete, in the majority of subjects. The system appeared to be clinically valuable and should be developed further. (Clinical trial registration number: DE/CA05/2009031008.).
机译:背景:胶囊内窥镜的远程控制可能允许对人的胃进行可靠的检查。目的:通过使用手持式外部磁体来评估在人胃中使用磁性材料(磁性可操纵胶囊[MMC])对改良型胶囊内窥镜进行操作的安全性和有效性。设计:开放临床试验。地点:学术医院。患者:十名健康志愿者。干预措施:受试者吞咽MMC和果子露粉以扩张胃。使用外部磁性拨片(EMP-2)操纵胃内的MMC。在实时显示MMC胶片的屏幕上评估MMC响应度。主要观察指标:安全性和耐受性(问卷调查),MMC在胃中的停留时间,对EMP-2的反应性,可视化的胃粘膜区域。结果:无不良事件发生。 MMC始终清楚地被EMP-2吸引,并对其动作做出了回应。它在胃中停留了39 +/- 24分钟。在7名受试者中,检查了card门和幽门,并且可视化了75%或更多的胃粘膜(在所有其余受试者中≥50%)。学习曲线清晰可辨(识别MMC定位,预期动作)。局限性:少量液体阻塞了眼底顶端部分的视野;胃胀气不足以平整所有胃褶。结论:使用手持磁铁对健康志愿者的胃中的MMC进行远程控制是安全可行的。在大多数受试者中,MMC的反应性非常好,并且胃黏膜的可视化很好,尽管还不完全。该系统似乎具有临床价值,应进一步开发。 (临床试验注册号:DE / CA05 / 2009031008。)。

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