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Endoscopy
DOI: 10.1055/a-2436-7933
Innovations and brief communications

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

Christoph Römmele 
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Mousa Ayoub
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Julia Wanzl
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Vidan Tadic
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Georg Braun
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Tobias Weber
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Markus Wolfgang Scheppach 
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
David Roser
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Katharina Matic
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Sandra Nagl
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Helmut Messmann
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
,
Alanna Ebigbo
1   Gastroenterology, Faculty of Medicine, University Hospital Augsburg, Augsburg, Germany (Ringgold ID: RIN39694)
› Author AffiliationsSupported by: ambu GmbH
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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.

Supplementary Material



Publication History

Received: 23 May 2024

Accepted after revision: 08 October 2024

Accepted Manuscript online:
08 October 2024

Article published online:
27 November 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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