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DOI: 10.1055/a-2436-7933
Clinical evaluation of a novel single-use therapeutic gastroscope: a pilot feasibility study
Supported by: ambu GmbH
Abstract
Background
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 single-use therapeutic gastroscope was recently approved in Europe, but clinical data to support its use are currently lacking. We aimed to evaluate the performance of this novel device in routine procedures requiring a large working channel.
Methods
Between January and May 2024, consecutive patients with an indication for therapeutic gastroscopy were included prospectively. The primary outcome was intraprocedural technical success rate.
Results
Eight gastrointestinal bleedings, two pancreatic necrosectomies, four foreign body removals, four stent placements, and two cryo-balloon ablations were performed. The technical success rate was 84% (16/19 patients). Crossover to a standard endoscope was required in three procedures. Clinical success was achieved in all cases with technical success. Overall user experience was 3.2 on a Likert scale of 1–5. No adverse events were reported.
Conclusions
The single-use therapeutic gastroscope demonstrated feasibility in various therapeutic procedures; however, a 16% crossover rate and fair user assessment score suggest that further technical improvements to the device are necessary.
Publication History
Received: 23 May 2024
Accepted after revision: 08 October 2024
Accepted Manuscript online:
08 October 2024
Article published online:
27 November 2024
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