The First Non-Surgical Anti-Stomal Prolapse Medical Device to Treat and Prevent Stomal Prolapse

ABSTRACT Intestinal stomas such as ileostomies and colostomies are openings of the intestinal tract surgically exteriorized onto the abdominal surface to divert enteric content away from distal cancer, obstruction, inflammation, and infection 5. In the US alone, about 1.5 million people have stomas14. Prolapse, or protrusion, of the bowel through the stoma is a common complication that can cause pain, stomal obstruction, bowel edema, bleeding, stool leakage, and ischemia 12. Stomal prolapse is treated acutely using manual reduction at the bedside or under general anesthesia but is prone to recur. In emergent cases, such as intestinal ischemia, a prolapse may require surgical intervention for reduction. The definitive treatment of stomal prolapse is an operation to revise the stoma and remove additional bowel 10. We have designed a novel device, the NoLapse, which prevents stomal prolapse non-operatively. The NoLapse has a semi-flexible silicone ring that is placed inside the intestinal lumen to dampen peristaltic movement. An accompanying sizing kit helps the user select the correct size. Our human emergency use case, preliminary benchtop, and cadaveric animal studies have demonstrated the efficacy and functionality of this system. The proposed research in this STTR application is designed to accomplish two goals: 1) advance the design and development of the NoLapse and 2) to begin animal studies to assess the safety and efficacy of the device in vivo. To develop the product, we will perform user validation and benchtop tests to select the materials, manufacturing methods, and designs involved in the NoLapse. The product, which includes the NoLapse device and its sizing kit, will be manufactured in collaboration with an ISO 13485 silicone manufacturer. To test the product in vivo, we will perform a laparotomy, create an ileostomy in 8 pigs, and record prolapse episodes. The NoLapse will be inserted on postoperative day 1 in the experimental group (n = 6), while any prolapses occurring in the control group (n = 2) will be manually reduced. The device will be removed after 24 hours (2 pigs), 1 week (2 pigs), or 2 weeks (2 pigs). After pigs are sacrificed at the 2-week time point, we will perform a necropsy and evaluate the histopathology to assess pressure necrosis. At the conclusion of the Phase 1 STTR grant, we will significantly advance the device’s design and development, complete animal studies, and reach the endpoints that inform product safety and efficacy. After successful completion of this work, we plan to apply for the Phase 2 STTR grant to further develop the product through human clinical trials and FDA regulatory and classification guidelines.NARRATIVE andamp; PUBLIC HEALTH RELEVANCE A common complication for people living with stomas (approximately 1.5 million in the US) is the stomal prolapse, which often leads to additional emergency room visits, hospitalizations, and surgical procedures. Development of the Anti-Stomal Prolapse Medical Device will allow for the medical treatment and prevention of stomal prolapse, decrease the substantial morbidity and costs associated with this complication, and prevent patients from undergoing unnecessary surgical procedures and frequent emergency room visits. This device will reduce the overall cost of medical care for patients who have stomas.