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

NCT05504434 | Completed

• 1 other identifier: MEC-2022-0285
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Single-use gastroscope; Equipment Contamination; Performance

Outcome Measures

Primary Outcomes (1)

• Performance of a single use gastroscope, Ambu aScope gastro, for esophagogastroduodenoscopy

  Is the endoscopist able to complete the desired diagnostics/therapeutics during the EGD

  4 months

Secondary Outcomes (4)

• Qualitative assessment of the single-use gastroscope

  4 months

• Complications of EGD

  4 months

• Incidence of switching to reusable endoscope

  4 months

• Time to complete procedure

  4 months

Study Arms (1)

Adults patients treated with single use gastroscope

EXPERIMENTAL

Patients will be treated with a single-use gastroscope instead of a reusable gastroscope. The procedure will be performed as normal, no additional actions will be performed.

Device: Single-use gastroscope

Interventions

Single-use gastroscope DEVICE

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

Adults patients treated with single use gastroscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is planned to undergo gastroscopy for any indication either outpatient or inpatient
• The subject is ≥ 18 years old
• Specifically for the Netherlands:
• \- The subject is capable to understand the information required to give informed consent

You may not qualify if:

• Terminally ill patients
• Patients whose condition in the opinion of the investigator would interfere with adequately assessing the study outcomes
• Patients that participate in other investigational studies which would interfere with the outcomes of this study

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Maag Lever Darm Stichting: collaborator
• Ambu A/S: collaborator

Study Sites (2)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Oslo University Hospital - Rikshospitalet

Oslo, Norway

Location

Related Publications (4)

• ASGE Standards of Practice Committee; Ben-Menachem T, Decker GA, Early DS, Evans J, Fanelli RD, Fisher DA, Fisher L, Fukami N, Hwang JH, Ikenberry SO, Jain R, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Dominitz JA, Cash BD. Adverse events of upper GI endoscopy. Gastrointest Endosc. 2012 Oct;76(4):707-18. doi: 10.1016/j.gie.2012.03.252. No abstract available.

  PMID: 22985638 BACKGROUND

• McCafferty CE, Aghajani MJ, Abi-Hanna D, Gosbell IB, Jensen SO. An update on gastrointestinal endoscopy-associated infections and their contributing factors. Ann Clin Microbiol Antimicrob. 2018 Oct 10;17(1):36. doi: 10.1186/s12941-018-0289-2.

  PMID: 30314500 BACKGROUND

• Ofstead CL, Buro BL, Hopkins KM, Eiland JE, Wetzler HP, Lichtenstein DR. Duodenoscope-associated infection prevention: A call for evidence-based decision making. Endosc Int Open. 2020 Dec;8(12):E1769-E1781. doi: 10.1055/a-1264-7173. Epub 2020 Nov 17.

  PMID: 33269310 BACKGROUND

• Bajolet O, Ciocan D, Vallet C, de Champs C, Vernet-Garnier V, Guillard T, Brasme L, Thiefin G, Cadiot G, Bureau-Chalot F. Gastroscopy-associated transmission of extended-spectrum beta-lactamase-producing Pseudomonas aeruginosa. J Hosp Infect. 2013 Apr;83(4):341-3. doi: 10.1016/j.jhin.2012.10.016. Epub 2013 Jan 20.

  PMID: 23337251 BACKGROUND

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Bruno, Professor

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multi-center prospective consecutive observational cases series study

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 17, 2022
• Study Start: July 4, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); NO (1)