权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

基本信息

批准号：
10676811
负责人：
TAMARA N FITZGERALD
金额：
$ 52.58万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10676811
关键词：
Abdomen Address Authorization documentation 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 Good Manufacturing Process Health Expenditures Home Hospitals Human Resources Image Immersion Income Industrialization Infection Instruction Interdisciplinary Study Intra-abdominal Laparoscopes Laparoscopic Surgical Procedures Lawyers 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 Qualifying 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 light emission loss of function low and middle-income countries manufacture manufacturing process manufacturing technology metal oxide operation optical fiber 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

项目摘要

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