Performance of a Single-use Gastroscope (aScope Gastro) for Esophagogastroduodenoscopy (FARE)
Primary Purpose
Gastroscopy, Esophagogastroduodenoscopy, Equipment Design
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Single-use gastroscope
Sponsored by
About this trial
This is an interventional treatment trial for Gastroscopy focused on measuring Single-use gastroscope, Equipment Contamination, Performance
Eligibility Criteria
Inclusion Criteria:
- Subject is planned to undergo gastroscopy for any indication either outpatient or inpatient
- The subject is ≥ 18 years old
- The subject is capable to understand the information required to give informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Erasmus Medical CenterRecruiting
- Oslo University Hospital - Rikshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adults patients treated with single use gastroscope
Arm Description
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.
Outcomes
Primary Outcome Measures
Performance of a single use gastroscope, Ambu aScope gastro, for esophagogastroduodenoscopy
Is the endoscopist able to complete the desired diagnostics/therapeutics during the EGD
Secondary Outcome Measures
Qualitative assessment of the single-use gastroscope
Qualitative assessment of the single-use gastroscope, Ambu aScope gastro, compared to the experience only having used re-usable devices by means of a questionnaire answered by the endoscopist post-EGD. The following characteristics will be rated on a 5 point Likert scale ranging from "much worse" to "much better":
Ease of intubation
Ease of intubating duodenum
Completeness of inspection of the upper digestive track
Image quality
Handling
Lighting
Color reproduction
Air delivery
Therapeutics
Complications of EGD
Complications of EGD including pain post-EGD, bleeding, perforation, and 30-day post-gastroscopy infection rates
Incidence of switching to reusable endoscope
Time to complete procedure
Full Information
NCT ID
NCT05504434
First Posted
July 22, 2022
Last Updated
August 30, 2023
Sponsor
Erasmus Medical Center
Collaborators
Maag Lever Darm Stichting, Ambu A/S
1. Study Identification
Unique Protocol Identification Number
NCT05504434
Brief Title
Performance of a Single-use Gastroscope (aScope Gastro) for Esophagogastroduodenoscopy
Acronym
FARE
Official Title
Performance of a Single-use Gastroscope (aScope Gastro) for Esophagogastroduodenoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Maag Lever Darm Stichting, Ambu A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Esophagogastroduodenoscopy (EGD) is an important tool in the diagnosis and treatment of upper gastrointestinal-disorders. It has broad range of indications including dysphagia, gastroesophageal reflux disease, esophageal strictures or upper gastrointestinal (GI) bleeding. It is a common procedure and is performed around 6.1 million times annually in the United States. However, performing endoscopy is not without risk and complications of EGD include perforation, bleeding, aspiration, and infection.
Endoscopy associated infection (EAI) can be endogenous, due to translocation of the patient's own microbial gut flora into the bloodstream, or exogenous as a result of contaminated equipment. The latter receives increased attention as several outbreaks have been reported past decades. 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. Many of the published outbreaks involved contaminated duodenoscopes. However, multiple outbreaks due to a contaminated gastroscopes have also been described. The prevalence of contaminated ready-to-use gastroscopes has rarely been studied. One study reported the contamination of ready-to-use gastroscopes to be 64% post-high-level disinfection (HLD), which went down to 9% post-storage.
It is probable that EAI's are underreported due to a lack of recognition of EAI's caused by sensitive microorganisms, sparse microbiological surveillance post-endoscopy or the possibly long duration between the endoscopy and the development of the infection. However, even if the risk of EAI is low, due to the large numbers of endoscopies performed worldwide the number of affected patients is significant.
Single use endoscopes would completely eliminate the risk of exogenous EAI's. Already multiple single-use duodenoscopes have been brought to the market whose performance seems be comparable to reusable duodenoscopes. To address the risk of contaminated gastroscopes, Ambu is a company who produced a single-use gastroscope, the Ambu® aScope™ gastro. It is a lightweight scope equipped with two LED lights for optimal illumination and a high-resolution digital camera. The aScope gastro has recently been CE-approved, but no studies about its performance in patients have been published
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroscopy, Esophagogastroduodenoscopy, Equipment Design, Equipment Contamination / Prevention & Control, Cross Infection / Prevention & Control, Disposable Equipment, Infection Control / Methods
Keywords
Single-use gastroscope, Equipment Contamination, Performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-center prospective consecutive observational cases series study
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adults patients treated with single use gastroscope
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Single-use gastroscope
Intervention Description
Adults patients are treated with a single use gastroscope instead of a reusable gastroscope
Primary Outcome Measure Information:
Title
Performance of a single use gastroscope, Ambu aScope gastro, for esophagogastroduodenoscopy
Description
Is the endoscopist able to complete the desired diagnostics/therapeutics during the EGD
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Qualitative assessment of the single-use gastroscope
Description
Qualitative assessment of the single-use gastroscope, Ambu aScope gastro, compared to the experience only having used re-usable devices by means of a questionnaire answered by the endoscopist post-EGD. The following characteristics will be rated on a 5 point Likert scale ranging from "much worse" to "much better":
Ease of intubation
Ease of intubating duodenum
Completeness of inspection of the upper digestive track
Image quality
Handling
Lighting
Color reproduction
Air delivery
Therapeutics
Time Frame
4 months
Title
Complications of EGD
Description
Complications of EGD including pain post-EGD, bleeding, perforation, and 30-day post-gastroscopy infection rates
Time Frame
4 months
Title
Incidence of switching to reusable endoscope
Time Frame
4 months
Title
Time to complete procedure
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen van der Ploeg, MD
Phone
+31650032327
Email
k.ploeg@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Bruno, Professor
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen van der Ploeg, MD
Email
k.ploeg@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Koen van der Ploeg, MD
First Name & Middle Initial & Last Name & Degree
Marco Bruno, Professor
Facility Name
Oslo University Hospital - Rikshospitalet
City
Oslo
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Aabakken, Professor
First Name & Middle Initial & Last Name & Degree
Lars Aabakken, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22985638
Citation
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.
Results Reference
background
PubMed Identifier
30314500
Citation
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.
Results Reference
background
PubMed Identifier
33269310
Citation
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.
Results Reference
background
PubMed Identifier
23337251
Citation
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.
Results Reference
background
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Performance of a Single-use Gastroscope (aScope Gastro) for Esophagogastroduodenoscopy
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