Purpose or Case Report: To identify the regulatory process for an innovative device that will create an airtight seal around the anus during anintussusception reduction procedure
Methods & Materials: After the conclusion of the animal laboratory study to identify the shape and size of the balloons, utility patent applications were submitted. The testing required by the FDA was conducted. They include the benchtop testing and a feasibility animal testing. Multiple different tests were conducted to evaluate the durability, reliability, and efficiency of the product. These tests evaluate the flow rate through the central lumen, the balloon inflation/deflation rate, product continuity, and burst rate of the balloons. A minimum of 5 catheters were utilized for each test.

A feasibility test was performed. This involved utilizing an anesthetized pig. The Cephus Catheter was inserted per rectum and the internal balloon was inflated under fluoroscopic guidance. The external balloon was inflated to until a seal was created. A dye was then introduced into the rectum through the central lumen. The colon was then insufflated with air. Fluoroscopic images were obtained of the distended colon. Additional, photos were taken at the rectum to record any leakage of dye.
Results: Twelve benchtop tests were performed on the catheter and identified that it was functional, durable, and safe. The feasibility test yielded a moderate rate for bowel distention and identified the absence of leakage around the anus.
Conclusions: The study identified that the catheter is functional, durable and safe for used on human. It also identified that the catheter creates an air tight seal around the anus. Therefore, the innovative device will improve the process of intussusception reduction. Upon FDA approval, the product will be used in a risk analysis clinical trial.