Clinical evaluation of a novel therapeutic single-use gastroscope: a pilot feasibility study.
Journal
Endoscopy
ISSN: 1438-8812
Titre abrégé: Endoscopy
Pays: Germany
ID NLM: 0215166
Informations de publication
Date de publication:
08 Oct 2024
08 Oct 2024
Historique:
medline:
9
10
2024
pubmed:
9
10
2024
entrez:
8
10
2024
Statut:
aheadofprint
Résumé
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.
Sections du résumé
BACKGROUND AND STUDY AIMS
OBJECTIVE
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.
PATIENTS AND METHODS
METHODS
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.
RESULTS
RESULTS
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.
CONCLUSIONS
CONCLUSIONS
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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Thieme. All rights reserved.
Déclaration de conflit d'intérêts
The single-use therapeutic gastroscopes used in this study were funded by the ambu GmbH. The study design, execution and manuscript preparation were carried out without any influence from the company. CR reports consulting fees from ambu Innovations and ambu GmbH, unpaid consultancies for Boston Scientific HM reports relationships with the following endoscopic companies: Ambu, Boston Scientific, Fujifilm, Hitachi, Olympus, has received honoraria from Olympus; has received consultation fees from ambu, Boston Scientific, Olympus. AE reports consulting fees from ambu and Olympus. The remaining authors and participating endoscopists declare no conflicts of interest.