Safety of Alginate-based Gastric Mucosal Protective Adhesive and Feasibility Study of Its Use as Submucosal Injection

Objective To study the safety of alginate based gastric mucosal protective adhesive and its feasibility as a submucosal injection. Methods The feasibility of using alginate-based gastric mucosal protective gel as submucosal injection was evaluated by in vitro gastric mucosal uplift test in pigs and in vivo gastric mucosal uplift test in rats. The safety of alginate based gastric mucosa protective adhesive was evaluated by cytotoxicity test, acute toxicity test and oral mucosa stimulation test according to GB/T 16886 series standard of biological evaluation of medical devices. Results After injection of different concentrations of alginate base mucosal protective adhesive solution, the uplift height was significantly higher than that of normal saline (P<0.05). Gastric mucosal protection glue has no cytotoxic oral mucosal irritation or acute toxicity. Conclusion Gastric mucosa protector is a promising new medical device product with feasibility and good biocompatibility as submucosal uplift injection agent.