Performance Metrics of a Novel Single-Use Therapeutic Gastroscope

OBJECTIVES: The FDA cleared the first single-use therapeutic gastroscope (SUTG) (4.2mm working channel) in April 2024. Compared to most reusable therapeutic gastroscopes (RTGs) (3.7mm), SUTGs provide increased suctioning abilities to help facilitate the evacuation of blood and retained contents from the upper gastrointestinal tract as well as increase safety. This study aimed to evaluate the performance of the novel SUTG.

METHODS: From April to June 2024, 17 physicians at 6 large university hospital systems in the United States completed 30 procedures requiring a therapeutic gastroscope (TG). After each procedure, physicians completed a survey to assess their experience and the clinical performance of the SUTG rated from 1 (very poor) to 5 (very good). The Ambu aScope Gastro Large (4.2mm) was utilized for all cases.

RESULTS: 93% (27/29) of the procedures were performed successfully with the SUTG. Insufflation connection issues prevented procedure completion in one case, while the SUTG or a RTG could not complete another, due to anatomy related complications. Additionally, scope length limitations prevented the SUTG from reaching a distal duodenum bleed in one case and was excluded from the study. The SUTG was rated greater than 4/5 in all 22 survey variables with distal attachment removal (4.93) and mounting (4.87) rating the highest. Physicians who performed hemostasis, food impaction, or foreign body removal rated suction without a tool a 4.72 and with an inserted tool a 4.25. The SUTG’s ergonomics was rated a 4.45.

CONCLUSIONS: The SUTG had a high success rate, wasn’t the cause of failure in any case, and received high ratings in all 22 categories measured. Every metric was rated at least a 4 out of 5 with the overall satisfaction rating a 4.64. The excellent therapeutic performance measured by the study demonstrates that the novel SUTG (Ambu aScope Gastro Large) may be a suitable alternative to RTGs.