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.

抽象的 腹腔镜手术是高收入国家许多胸部癌症手术的标准治疗方法 和腹部。腹腔镜手术通过使用微型相机和精密仪器避免了大切口 通过锁孔切口进行操作，但在低收入和中等收入国家通常不可用 （中低收入国家）由于安装成本高、缺乏合格的维护人员、电力不稳定 以及消耗品短缺。中低收入国家的患者将受益于腹腔镜手术，因为 优点包括：减轻疼痛、缩短恢复时间、减少伤口感染和缩短住院时间 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 专为中低收入国家的资源、需求和挑战而设计。 KeyScope 是一种腹腔镜，可以 售价 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 单个单元，无需复杂的组装，可通过浸泡在 Cidex 中进行消毒。它链接到远程指导 应用程序，以便经验丰富的外科医生可以指导外科医生建立能力建设伙伴关系。 KeyLoop 是一个 腹腔镜牵开器，可在手术过程中抬起腹壁，无需恒定动力 供应和医用级二氧化碳。这将使腹腔镜手术能够在农村进行 大多数患者居住在中低收入国家的医院，并增加接受腹腔镜手术的三级中心的使用机会 设备稀有且昂贵。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 到下一阶段。 我们将在乌干达癌症研究所进行临床首次人体研究。乌干达外科医生将使用 KeySuite 设备用于对腹内肿瘤进行活检。主要结果将是执行能力 腹腔镜活检，无需转为开腹手术。次要结果包括：1) 设备 可行性和安全性数据以及 2) 患者满意度。 我们将证明 KeySuite 设备可以通过 Duke-MUK Shipping 在乌干达建造 容器创客空间。我们将创建物料清单、制造工艺说明、培训视频、 和质量控制措施。一旦我们达到了卓越的施工质量，我们将把这个 与乌干达工业研究所 (UIRI) 合作，该研究所将把 KeySuite 转变为产品 商业化。我们将利用世界卫生组织良好生产规范 (GMP) 建立质量保证 可持续本地制造协议以及 KeyScope 和 KeyLoop 的监管批准 乌干达国家药品管理局和 CE 标志。