KeyScope: The Key to Sustainable Cancer Diagnosis and Treatment in Uganda

KeyScope：乌干达可持续癌症诊断和治疗的关键

• 批准号: 10416540
• 负责人: TAMARA N FITZGERALD
• 金额: $ 58.88万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-04 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10416540
• 关键词: Abdomen; Address; Biomedical Engineering; Biopsy; Businesses; Carbon Dioxide; Chest; Cidex; Classification; Client satisfaction; Clinical; Collaborations; Color; Computers; Contract Services; Country; Data; Devices; Electricity; Engineering; Ensure; Equipment; Excision; Fiber Optics; Foundations; Gases; Health Expenditures; Health Services Accessibility; Home; Hospitals; Human Resources; Image; Immersion; Income; Industrialization; Infection; Institutes; Instruction; Interdisciplinary Study; Intra-abdominal; Laparoscopes; Laparoscopic Surgical Procedures; Lawyers; Lead; Length of Stay; Lifting; Light; Link; Maintenance; Malignant Neoplasms; Malignant neoplasm of abdomen; Maryland; Measures; Mechanics; Medical; Mentors; Monitor; Oncologist; Operating Rooms; Operative Surgical Procedures; Pain; Pathologic; Pathway interactions; Patients; Performance; Pharmaceutical Preparations; Poverty; Power Sources; Procedures; Process; Production; Protocols documentation; Quality Control; Radiation; Recovery; Regulation; Research Institute; Resource-limited setting; Resources; Rural Hospitals; Safety; Semiconductors; Shipping; Source; Surgeon; Surgical incisions; System; Technology; Testing; Time; Tissues; Training; Uganda; Universities; Work; Wound Infection; abdominal wall; authority; cancer care; cancer diagnosis; cancer therapy; cardiovascular collapse; chemotherapy; commercialization; cost; design; detector; experience; first-in-human; global health; health care delivery; human study; improved; instrument; interdisciplinary approach; laptop; loss of function; low and middle-income countries; manufacturing process; metal oxide; operation; patient safety; porcine model; predicting response; pressure; prevent; primary outcome; product development; prototype; quality assurance; repaired; safety and feasibility; secondary outcome; social stigma; standard of care; success; tumor; willingness

Abstract Laparoscopic surgery is the standard of care in high-income countries for many cancer operations in the chest and abdomen. Laparoscopic surgery avoids large incisions by using a tiny camera and fine instruments manipulated through keyhole incisions, but it is generally unavailable in low- and middle-income countries (LMICs) due to high cost of installment, lack of qualified maintenance personnel, unreliable electricity and shortage of consumable items. Patients in LMICs would benefit from laparoscopic surgery, as advantages include: decreased pain, improved recovery time, fewer wound infections, and shorter hospital stays. Laparoscopic surgery would reduce recovery time, enabling patients to return to home and work more quickly, thereby mitigating impoverishing health expenditure. KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that we have designed for the resources, needs and challenges of LMICs. KeyScope is a laparoscope that can be made for $150 (cost of goods), plugs into a laptop computer to display images during surgery, exists as a single unit without complicated assembly and is sterilizable by immersion in Cidex. It links to a tele-mentoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide. This would enable laparoscopic surgery to be performed in rural hospitals, where most patients live in LMICs, and increase access in tertiary centers where laparoscopic equipment is rare and expensive. We describe a multi-disciplinary collaboration between surgeons, engineers, oncologists, attorneys, global health experts and business executives to take this technology to the next stage. We will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors. Primary outcome will be the ability to perform biopsies laparoscopically without conversion to open surgery. Secondary outcomes include: 1) device feasibility and safety data and 2) patient satisfaction. We will demonstrate that KeySuite devices can be constructed in Uganda, through the Duke-MUK Shipping Container Makerspace. We will create a bill of materials, manufacturing process instructions, training videos, and measures of quality control. Once we have achieved exceptional construction quality, we will transfer this work to the Uganda Industrial Research Institute (UIRI) which will move the KeySuite to a product for commercialization. Using the WHO Good Manufacturing Practices (GMP) we will establish quality assurance protocols for sustainable local manufacturing and regulatory approval of the KeyScope and KeyLoop through the Uganda National Drug Authority and CE mark.

摘要 在高收入国家，腹腔镜手术是许多胸部癌症手术的标准护理方式。 还有腹部。通过使用微型摄像机和精细器械，腹腔镜手术避免了大的切口 通过锁孔切割进行操作，但在低收入和中等收入国家通常无法获得 (LMICs)由于安装成本高，缺乏合格的维护人员，电力不可靠 和消费品的短缺。LMICs中的患者将从腹腔镜手术中受益，因为 优点包括：减轻疼痛，缩短恢复时间，减少伤口感染，缩短住院时间。 留下来。腹腔镜手术将缩短康复时间，使患者能够更多地回家工作 迅速，从而减轻贫困的卫生支出。 KeyScope和KeyLoop(统称为KeySuite)是我们拥有的腹腔镜原型 专为LMIC的资源、需求和挑战而设计。KeyScope是一种腹腔镜，可以 制造成本为150美元(商品成本)，插入笔记本电脑以在手术期间显示图像，作为一种 单个组件，无需复杂的组装，可浸泡在Cidex中进行灭菌。它链接到一个远程辅导 应用程序，以便有经验的外科医生可以在能力建设伙伴关系中指导外科医生。KeyLoop是一个 在手术中提升腹壁的腹腔镜式拉钩，不需要持续的动力 供应和医用级别的二氧化碳。这将使腹腔镜手术能够在农村地区进行。 大多数患者住在LMICs的医院，并增加在腹腔镜检查的三级中心的准入 设备稀少，价格昂贵。我们描述了外科医生之间的多学科合作， 工程师、肿瘤学家、律师、全球健康专家和企业高管采用这项技术 进入下一阶段。 我们将在乌干达癌症研究所进行一项临床首例人类研究。乌干达外科医生将使用 KeySuite设备用于对腹部肿瘤进行活组织检查。主要结果将是有能力执行 在不中转开腹手术的情况下进行腹腔镜活组织检查。次要结果包括：1)设备 可行性和安全性数据；2)患者满意度。 我们将演示KeySuite设备可以通过Duke-Muk Shipping在乌干达建造 集装箱制造空间。我们将创建材料清单、制造工艺说明、培训视频、 以及质量控制措施。一旦我们实现了卓越的建筑质量，我们将把这一点 与乌干达工业研究所(UIRI)合作，该研究所将把KeySuite转移到用于 商业化。我们将利用世界卫生组织的良好制造规范(GMP)建立质量保证 KeyScope和KeyLoop通过的可持续本地制造和监管批准协议 乌干达国家药监局和CE标志。