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.

Project Narrative Laparoscopic surgery is the standard of care in high-income countries for many cancer procedures but is largely inaccessible in low- and middle-income countries. We describe a multi-disciplinary collaboration between biomedical engineers, surgeons, oncologists, global healthcare delivery teams and business developers to move a low-cost and durable laparoscopic system to the next stage. Construction of the laparoscopic system will be demonstrated in Uganda, its clinical performance will be tested in a clinical First-in- Human study and regulatory approval will be achieved to bring this system to commercialization in Uganda.