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Medical Device to Enhance Colorectal Cancer Screening via More Efficient Applicat

医疗设备通过更高效的应用来加强结直肠癌筛查

基本信息

批准号：
8523430
负责人：
Jeff Vasek
金额：
$ 14.42万
依托单位：
ENDOCOLE, LLC
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-06-01 至 2014-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8523430
关键词：
Anesthesia procedures Animal Model Animals Cancer Control Clinical Data Clinical Research Clinical assessments Colon Colon Carcinoma Colonoscopes Colonoscopy Colorectal Cancer Cost Control Development Devices Engineering Excision Family suidae Feasibility Studies Fees Financial cost Gastroenterologist Goals Hand Health Care Costs Healthcare Healthcare Systems Human Investments Length Measures Medical Medical Device Methods Modeling Outcome Pain Pathology Patients Performance Phase Physicians Polyps Prevention Procedures Recovery Rectum Reporting Secure Sedation procedure Simulate Testing Time Tissues Transportation Tube Video Recording Work base cancer prevention colorectal cancer screening commercialization cost design experience improved lost work time novel payment phase 1 study phase 2 study pressure prototype public health relevance screening tool

项目摘要

DESCRIPTION (provided by applicant): Colonoscopy is the preferred tool for colorectal cancer screening and polyp removal but the procedure carries a high financial cost. Minimizing the use of sedation/anesthesia and reducing the challenges associated with colonoscope insertion would significantly reduce this cost. EndoCole proposes to develop a low-cost medical guide device that is inserted before the colonoscope and that enables easy insertion of the colonoscope to reduce the need for sedation and improve the overall efficiency of the procedure. Phase I of this project will be to: 1) design and build a prototype device for feasibiliy testing and 2) to validate that device via animal studies conducted by a practicing gastroenterologist. Phase II of the project will test this device in a human clinical study. If oveall development is successful, EndoCole plans to commercialize a medical device that will allow for more efficient, less painful and less costly colonoscopies.

描述(由申请人提供)：结肠镜检查是结直肠癌筛查和息肉切除的首选工具，但该程序具有较高的经济成本。最大限度地减少镇静/麻醉的使用并减少与结肠镜插入相关的挑战将显著降低这一成本。EndoCole建议开发一种低成本的医疗引导装置，该装置可以插入结肠镜之前，使结肠镜能够轻松插入，以减少对镇静的需要，并提高手术的整体效率。该项目的第一阶段将是：1)设计和制造用于可行性测试的原型设备；2)通过由执业胃肠病专家进行的动物研究来验证该设备。该项目的第二阶段将在人体临床研究中测试该设备。如果Oveall的开发成功，EndoCole计划将一种医疗设备商业化，这种设备将允许更有效、更少痛苦和更低成本的结肠镜检查。