ERCPASSURENCT05225909
aScope Single Use ERCP Study- ASSURE Study
An observational study of ERCP and Cholangitis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients undergo ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as common bile duct (CBD)stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post-ERCP is around one in 200. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ERCP, Cholangitis, Infection
- What is being tested?
- Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscope
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jul 2022to 31 Mar 2025
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population studied will be patients who need ERCP procedure. All consecutive patients who are referred for ERCP will be screened to see if they meet the eligibility criteria to participate in the study.
Who may be able to join
- Patients who are at high risk of post ERCP infection such as
- Jaundice (Bilirubin >21)
- Primary sclerosing cholangitis
- Post liver transplant anastomotic stricture
- Inpatients
- Combined procedures (Ex: ERCP+ spy glass cholangioscopy)
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- Previous inadequate biliary drainage.
- Biliary stricture
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Grade 1-3 ERCP on complexity grading (ASGE grading)
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Patients with CBD stones and no jaundice
- Sphincter of Oddi manometry.
- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Patients who are unable to consent for the study.
- ERCP for Pancreatic pathology.
- Grade 4 complex ERCP (ASGE grading)
- Participant who is terminally ill /ECOG 4
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottingham, Ng7 2UH
About this study
Official title: Multi-centre Prospective Observational Cohort Study: To Assess the Performance of Single Use Duodenoscope (aScope)
Patients undergo ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as common bile duct (CBD)stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post-ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS). There are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. The investigators do not know what percentage of infection is secondary to the above. The new single use duodenoscope (aScope, Ambu Ltd) has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked but the evidence for performance of the aScope is limited. The investigators want to assess the performance of the scope simultaneously in multiple different hospitals. In addition, the investigators also want to assess the cost consequence to the NHS for using the above scope. Hence, the investigators want to assess the performance of the scope in the high risk groups for infection.
Read the detailed description
ERCP is a therapeutic endoscopic procedure done to establish either bile duct or pancreatic duct drainage or both. The indications for ERCP are bile duct stones, bile duct strictures, sphincter of Oddi manometry with sphincterotomy, bile leak, pancreatic duct stones and pancreatic duct stricture. The intended benefits of the procedure are either to relieve bile duct/ pancreatic duct obstruction or facilitate bile duct/ pancreatic duct drainage. It is a minimally invasive procedure and is associated with reduced morbidity compared to surgery.
Gall stones are made of cholesterol, pigment and mixture of cholesterol and pigment. The incidence of stones with in the bile-duct varies from 4.6% to 19%.The stones are predominantly formed in the gall bladder and are displaced from the gall bladder in to the bile duct via the cystic duct. ERCP is an effective and minimally invasive treatment for bile duct stones. Treatment of extrahepatic biliary strictures; irrespective of their aetiology, is to place a stent across the stricture through ERCP and facilitate biliary drainage.
There is emerging data that the incidence of carbapenem resistant enterobacteriae, Multidrug-resistant Klebsiella pneumoniae, and New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli (CRE) following exposure to contaminated duodenoscopes (ERCP endoscopes). The main reason for the outbreaks is due to inadequate reprocessing (Cleaning of endoscope post procedure) leading to contamination of endoscopes. To minimize the risk of contamination and outbreak of above infections, single use disposable duodenoscopes have been brought in to the market. The aim of the study is to assess the performance of the single use duodenoscope and the cost consequences associated with the above.
- Conditions
- ERCP, Cholangitis, Infection
- Being tested
- Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscope
- Keywords
- aScope, Ambu Ltd
- Medical subject headings
- Cholangitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscopeDevice
ERCP Procedure will be done using aScope. We will assess the performance of the aScope.
| Study group | Role | What they receive |
|---|---|---|
| Patients who Undergo ERCP procedure with aScope | This will be patients who undergo ERCP procedure using aScope. Receives: Device: Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion the intended ERCP procedure with single use duodenoscope.
To assess if the intended ERCP procedure can be successfully completed with single use disposable duodenoscope.
Measured: 60-120 minutes
Secondary outcomes (3)
Rate of complications
Complications associated with the procedure such as bleeding, pancreatitis, post-ERCP infection and perforation
Measured: 30 days post procedure
Endoscopy metrics
Endoscopy metric will be assessed through a agreed, structured questionnaire
Measured: 15 minutes after the procedure
Quality of life following the procedure
Quality of life will me measured using validated questionnaire
Measured: 5 minutes on day 7 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start5 Jul 2022
- Primary completion21 Jan 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suresh V Venkatachalapathy, MRCP, Study chair, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225909
- Sponsor's protocol ID
- 21GA088
- Acronym
- ASSURE
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: National research ethics committee does not allow sharing individual participant data because of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Prospective Observational Cohort Study: To Assess the Performance of Single Use Duodenoscope (aScope)
- ClinicalTrials.gov ID
- NCT05225909
- Acronym / sponsor ID
- ASSURE / 21GA088
- Conditions
- ERCP, Cholangitis, Infection
- Keywords
- aScope, Ambu Ltd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 7 Feb 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.
Patients undergo ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as common bile duct (CBD)stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post-ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS). There are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. The investigators do not know what percentage of infection is secondary to the above. The new single use duodenoscope (aScope, Ambu Ltd) has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked but the evidence for performance of the aScope is limited. The investigators want to assess the performance of the scope simultaneously in multiple different hospitals. In addition, the investigators also want to assess the cost consequence to the NHS for using the above scope. Hence, the investigators want to assess the performance of the scope in the high risk groups for infection.
Detailed description
ERCP is a therapeutic endoscopic procedure done to establish either bile duct or pancreatic duct drainage or both. The indications for ERCP are bile duct stones, bile duct strictures, sphincter of Oddi manometry with sphincterotomy, bile leak, pancreatic duct stones and pancreatic duct stricture. The intended benefits of the procedure are either to relieve bile duct/ pancreatic duct obstruction or facilitate bile duct/ pancreatic duct drainage. It is a minimally invasive procedure and is associated with reduced morbidity compared to surgery.
Gall stones are made of cholesterol, pigment and mixture of cholesterol and pigment. The incidence of stones with in the bile-duct varies from 4.6% to 19%.The stones are predominantly formed in the gall bladder and are displaced from the gall bladder in to the bile duct via the cystic duct. ERCP is an effective and minimally invasive treatment for bile duct stones. Treatment of extrahepatic biliary strictures; irrespective of their aetiology, is to place a stent across the stricture through ERCP and facilitate biliary drainage.
There is emerging data that the incidence of carbapenem resistant enterobacteriae, Multidrug-resistant Klebsiella pneumoniae, and New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli (CRE) following exposure to contaminated duodenoscopes (ERCP endoscopes). The main reason for the outbreaks is due to inadequate reprocessing (Cleaning of endoscope post procedure) leading to contamination of endoscopes. To minimize the risk of contamination and outbreak of above infections, single use disposable duodenoscopes have been brought in to the market. The aim of the study is to assess the performance of the single use duodenoscope and the cost consequences associated with the above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who Undergo ERCP procedure with aScope | – | Device: Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscopeThis will be patients who undergo ERCP procedure using aScope. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied will be patients who need ERCP procedure. All consecutive patients who are referred for ERCP will be screened to see if they meet the eligibility criteria to participate in the study.
Key inclusion criteria (13 listed)
- Patients who are at high risk of post ERCP infection such as
- Jaundice (Bilirubin >21)
- Primary sclerosing cholangitis
- Post liver transplant anastomotic stricture
- Inpatients
Key exclusion criteria (8 listed)
- Patients with CBD stones and no jaundice
- Sphincter of Oddi manometry.
- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Patients who are unable to consent for the study.
- ERCP for Pancreatic pathology.
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 |
|---|---|---|
| Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscopeERCP Procedure will be done using aScope. We will assess the performance of the aScope. | Device | Patients who Undergo ERCP procedure with aScope |
Primary outcome
Completion the intended ERCP procedure with single use duodenoscope.
Time frame: 60-120 minutes
To assess if the intended ERCP procedure can be successfully completed with single use disposable duodenoscope.
3 secondary outcomes
Rate of complications
Time frame: 30 days post procedure
Endoscopy metrics
Time frame: 15 minutes after the procedure
Quality of life following the procedure
Time frame: 5 minutes on day 7 and 30
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 22 Jan 2026.
- Individual participant dataSharing planned: No. National research ethics committee does not allow sharing individual participant data because of confidentiality
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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.
Suresh V Venkatachalapathy, MRCP study chair
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ERCP and Cholangitis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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 13 inclusion and 8 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Completion the intended ERCP procedure with single use duodenoscope. (time frame: 60-120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.