Clinical evaluation of a novel therapeutic single-use gastroscope: a pilot feasibility study.

Abstract

The trend toward disposable products in gastrointestinal endoscopy, including single-use endoscopes, remains undeterred, even though crucial questions of sustainability and performance have not been sufficiently studied. The first therapeutic single-use gastroscope (Ambu aScope Gastro Large) was recently approved in Europe, but clinical data to support its use is currently unavailable. We aimed to evaluate the performance of the Ambu aScope Gastro Large in routine procedures requiring a large working channel. Between January and May 2024, consecutive patients with an indication for therapeutic gastroscope use were included prospectively. The primary aim was to assess the intraprocedural technical success rate. Eight gastrointestinal bleedings, two pancreatic necrosectomies, four foreign body removals, four stent implantations, and two cryoablations were performed. The technical success rate was achieved in 16 out of 19 (84%) patients. Three crossovers to standard endoscopes occurred. Clinical success was achieved in all cases where the primary aim was achieved (85%). No adverse events were reported. The therapeutic single-use gastroscope demonstrated feasibility in various therapeutic procedures, however, a crossover rate of 16% and an average user quality assessment score of 3.2 on the Likert scale suggest that further technical improvements of the device are necessary.