A magnetic capsule endoscope for colonoscopy in patients with IBD

用于 IBD 患者结肠镜检查的磁性胶囊内窥镜

• 批准号: 9305077
• 负责人: Keith L Obstein
• 金额: $ 37.65万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-18 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9305077
• 关键词: Address; Adopted; Adverse event; American; Anatomy; Animals; Automobile Driving; Benchmarking; Benign; Biopsy; Cadaver; Child; Clinical; Clinical Trials; Collection; Colon; Colonoscopes; Colonoscopy; Colorectal Cancer; Computer Assisted; Coupling; Crohn' s disease; Detection; Development; Device Designs; Devices; Diagnosis; Diagnostic; Endoscopes; Endoscopy; Engineering; Excision; Family suidae; General Population; Goals; Head; Human; Inflammatory Bowel Diseases; Insufflation; Intervention; Intubation; Intuition; Learning; Lesion; Life; Location; Locomotion; Magnetism; Measures; Mechanics; Mesentery; Modeling; Monitor; Motion; Nursing Faculty; Occupations; Painless; Patients; Perforation; Phase; Polyps; Positioning Attribute; Procedures; Protocols documentation; Regulation; Research Personnel; Resistance; Risk; Robotics; Safety; Sedation procedure; Stretching; Surveillance Program; System; Technical Degree; Technical Expertise; Techniques; Technology; Testing; Therapeutic; Therapeutic Intervention; Time; Translational Research; Ulcerative Colitis; Universities; Validation; Work; arm; base; capsule; clinical application; cost; design; diagnostic accuracy; experience; flexibility; gastrointestinal; improved; in vivo; innovation; instrument; lifetime risk; outcome forecast; pre-clinical; prevent; public health relevance; robot assistance; robot control; rural area; skills; success; tool; young adult

DESCRIPTION (provided by applicant): We propose to develop, optimize, and pre-clinically assess a robotic platform that may provide a safer alternative to standard colonoscopy for patients with Inflammatory Bowel Disease (IBD). Patients with IBD are at increased risk for colorectal cancer and therefore surveillance has been recommended to occur at a shorter interval than that recommended for the general population. Therefore, over the course of an IBD patient's lifetime, they are subjected to a significantly larger number of colonoscopies than their non-IBD counterparts, resulting in a more than 6-fold increase in post-procedure adverse events. The main risks of colonoscopy are those related to procedural sedation, patient discomfort, or perforation of the colon from looping. Looping and mesenteric stretching occur due to the design of the colonoscope. Special maneuvers can be performed to minimize looping, making colonoscopy a procedure that requires a great degree of technical skill and experience to safely perform. Capsule endoscopy has already been extremely helpful for IBD patients, especially in the diagnosis of Crohn's disease in children and young adults. Adapting capsule endoscopy to colonoscopy as proposed by this project would allow for reduced risk of adverse events, thus providing great benefit to patients with IBD. By using the robotic platform we propose, the endoscopist will be able to remotely control the motion of a soft-tethered capsule to perform diagnosis and treatment at any location inside the human colon. Manipulation of the capsule is achieved by magnetic coupling, thanks to the interaction of two permanent magnets - one integrated inside the capsule and the other placed at the end effector of a robotic arm. Leveraging extensive preliminary results, with this study we will develop a fully vetted system ready for human clinical trials, and we will test the hypothesis that our approach has diagnostic and therapeutic capabilities comparable to standard colonoscopy, while at the same time, shortening the learning curve and decreasing both the degree of looping and mesenteric stretching. We will pursue these goals by (1) optimizing our robotic platform for human use, (2) implementing a safe, robust, and intuitive control, and (3) benchmarking the proposed technology with standard colonoscopy involving three different tiers. The Investigative Team, combining engineering and clinical faculty from Vanderbilt University, is uniquely positioned to achieve the success of this study. Specifically, the Investigators collectively possess expertise in endoscopic device design, clinical colonoscopy, assessment and validation of innovative gastrointestinal technologies, and translation of research-engineering developments into clinical applications. If successful, this approach will widen the implementation of IBD surveillance programs to rural areas thanks to the low cost of the platform (i.e., less than $20,000), ease of transport, no need for anesthesiologists or sedation monitors, and no need for specialized facilities within which examinations are performed.

描述（由申请人提供）：我们建议对机器人平台开发，优化和评估机器人平台，该平台可能为炎症性肠病（IBD）患者提供标准结肠镜检查的更安全替代品。 IBD患者患结直肠癌的风险增加，因此，建议以较短的间隔进行监视，而不是针对普通人群的建议。因此，在IBD患者的一生中，他们的结肠镜数量要大得多 非IBD对应物，导致过程后不良事件增加了6倍以上。结肠镜检查的主要风险是与程序性镇静，患者不适或结肠穿孔有关的风险。循环和肠系膜拉伸是由于结肠镜的设计而发生的。可以执行特殊的操纵以最大程度地减少循环，从而使结肠镜检查成为需要大量的技术技能和经验来安全执行的程序。胶囊内窥镜检查对IBD患者已经非常有帮助，尤其是在诊断儿童和年轻人的克罗恩病时。根据该项目提出的适应胶囊内窥镜检查对结肠镜检查，将允许降低不良事件的风险，从而为IBD患者提供巨大的好处。通过使用我们提出的机器人平台，内窥镜医生将能够远程控制软束缚胶囊的运动，以在人类结肠内的任何位置进行诊断和治疗。由于两个永久磁体的相互作用 - 一个集成在胶囊内，另一个放置在机器人臂的末端效应器上，可以通过磁耦合来实现胶囊的操作。利用广泛的初步结果，通过这项研究，我们将完全发展 审查的系统准备进行人类临床试验，我们将检验以下假设：我们的方法具有与标准结肠镜检查相当的诊断和治疗能力，同时，缩短了学习曲线并降低了循环和肠系膜拉伸的程度。我们将通过（1）优化人工使用的机器人平台来实现这些目标，（2）实施安全，健壮和直观的控制，以及（3）用涉及三个不同层的标准结肠镜检查对提议的技术进行基准测试。调查团队将范德比尔特大学的工程和临床教师结合在一起，在实现这项研究的成功方面具有独特的位置。具体而言，研究人员在内窥镜装置设计，临床结肠镜检查，创新胃肠道技术的评估和验证方面统称具有专业知识，以及将研究工程发展转化为临床应用的转换。如果成功的话，这种方法将由于平台的低成本（即少于20,000美元），易于运输，不需要麻醉学家或镇静监测员，可以扩大对农村地区的IBD监视计划的实施，并且不需要对专业设施进行检查。