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Performance of a Single-use Gastroscope (aScope Gastro) for Esophagogastroduodenoscopy

NCT05504434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-08

No results posted yet for this study

Summary

Several infectious outbreaks have been described in the literature as a result of contaminated endoscopes. These endoscopes cannot be sterilized and require an extensive cleaning process in which breaches of cleaning protocols, endoscope damage or the formation of biofilm can prevent proper disinfection. The risk of endoscopy associated infection (EAI) and colonization due to contaminated endoscopes is still considered to be low. However, it is likely that there is severe underreporting of outbreaks due to a lack of recognition or assuming an infection to be endogenous. Due to the sheer volume of upper-gastrointestinal endoscopy worldwide, even with a low risk of EAI, the number of affected patients is significant. In response, several manufacturers have turned to the production of single-use endoscopes that eliminate the risk of exogenous infections. There are single use duodenoscopes on the market that almost seem to match the performance of reusable duodenoscopes. A new single use sterile gastroscope, Ambu aScope gastro, has been developed whose performance has not been previously described in patients. This multicenter single arm consecutive case series study will test the performance of these single use gastroscopes in patients undergoing esophagogastroduodenoscopy.

Conditions

  • Gastroscopy
  • Esophagogastroduodenoscopy
  • Equipment Design
  • Equipment Contamination / Prevention & Control
  • Cross Infection / Prevention & Control
  • Disposable Equipment
  • Infection Control / Methods

Interventions

DEVICE

Single-use gastroscope

Adults patients are treated with a single use gastroscope instead of a reusable gastroscope

Sponsors & Collaborators

  • Maag Lever Darm Stichting

    collaborator OTHER

  • Ambu A/S

    collaborator INDUSTRY

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Marco Bruno, Professor · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2023-12-01
Completion
2023-12-30

Countries

  • Netherlands
  • Norway

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504434 on ClinicalTrials.gov