GastroscopyFARENCT05504434
Performance of a Single-use Gastroscope (aScope Gastro) for Esophagogastroduodenoscopy
A study testing Single-use gastroscope in people with Gastroscopy and Esophagogastroduodenoscopy, run by Erasmus Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroscopy, Esophagogastroduodenoscopy, Equipment Design
- What is being tested?
- Single-use gastroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Jul 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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
- Conditions
- Gastroscopy, Esophagogastroduodenoscopy, Equipment Design, Equipment Contamination / Prevention & Control, Cross Infection / Prevention & Control, Disposable Equipment
- Being tested
- Single-use gastroscope
- Keywords
- Single-use gastroscope, Equipment Contamination, Performance
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-use gastroscopeDevice
Adults patients are treated with a single use gastroscope instead of a reusable gastroscope
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Single-use gastroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of a single use gastroscope, Ambu aScope gastro, for esophagogastroduodenoscopy
Is the endoscopist able to complete the desired diagnostics/therapeutics during the EGD
Measured: 4 months
Secondary outcomes (4)
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
Measured: 4 months
Complications of EGD
Complications of EGD including pain post-EGD, bleeding, perforation, and 30-day post-gastroscopy infection rates
Measured: 4 months
Incidence of switching to reusable endoscope
Measured: 4 months
Time to complete procedure
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start4 Jul 2022
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastroscopyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-center prospective consecutive observational cases series study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maag Lever Darm Stichting, Ambu A/S
- Responsible party
- Principal investigator, Marco J. Bruno, Erasmus Medical Center
- Investigators
- Marco Bruno, Professor, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504434
- Sponsor's protocol ID
- MEC-2022-0285
- Acronym
- FARE
- Status last verified
- Feb 2024
- First submitted
- 22 Jul 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22985638McCafferty 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.
PubMed 30314500Ofstead 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.
PubMed 33269310Bajolet 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.
PubMed 23337251
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of a Single-use Gastroscope (aScope Gastro) for Esophagogastroduodenoscopy
- ClinicalTrials.gov ID
- NCT05504434
- Acronym / sponsor ID
- FARE / MEC-2022-0285
- Conditions
- Gastroscopy, Esophagogastroduodenoscopy, Equipment Design, Equipment Contamination / Prevention & Control, Cross Infection / Prevention & Control, Disposable Equipment
- Keywords
- Single-use gastroscope, Equipment Contamination, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Maag Lever Darm Stichting, Ambu A/S
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center prospective consecutive observational cases series study
| Arm | Type | Receives |
|---|---|---|
| Adults patients treated with single use gastroscope | Experimental | Device: Single-use gastroscopePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-use gastroscopeAdults patients are treated with a single use gastroscope instead of a reusable gastroscope | Device | Adults patients treated with single use gastroscope |
Primary outcome
Performance of a single use gastroscope, Ambu aScope gastro, for esophagogastroduodenoscopy
Time frame: 4 months
Is the endoscopist able to complete the desired diagnostics/therapeutics during the EGD
4 secondary outcomes
Qualitative assessment of the single-use gastroscope
Time frame: 4 months
Complications of EGD
Time frame: 4 months
Incidence of switching to reusable endoscope
Time frame: 4 months
Time to complete procedure
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 22985638ASGE 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.
- Background: PubMed 30314500McCafferty 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.
- Background: PubMed 33269310Ofstead 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.
- Background: PubMed 23337251Bajolet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Bruno, Professor principal investigator
Erasmus Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-use gastroscope in people with Gastroscopy and Esophagogastroduodenoscopy, run by Erasmus Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of a single use gastroscope, Ambu aScope gastro, for esophagogastroduodenoscopy (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504434, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.