NCT05504434: FARE

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

Completed NA Last updated 8 February 2024

What this trial tests

NA trial testing Single-use gastroscope in Gastroscopy in 60 participants. Completed in 30 December 2023.

Timeline

4 July 2022

Primary endpoint
1 December 2023

30 December 2023

Quick facts

Lead sponsor	Erasmus Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	4 July 2022
Primary completion	1 December 2023
Estimated completion	30 December 2023
Sites	2 locations across Netherlands, Norway

Drugs / interventions tested

• Single-use gastroscope

Conditions studied

• Gastroscopy — all drugs for Gastroscopy →
• Esophagogastroduodenoscopy — all drugs for Esophagogastroduodenoscopy →
• Equipment Design — all drugs for Equipment Design →
• Equipment Contamination / Prevention & Control — all drugs for Equipment Contamination / Prevention & Control →

Sponsor

Erasmus Medical Center

Who can join

18 and older, any sex, with Gastroscopy or Esophagogastroduodenoscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.