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aScope Single Use ERCP Study- ASSURE Study

NCT05225909 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2026-01-22

No results posted yet for this study

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. 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.

Conditions

Interventions

DEVICE

Endoscopic retrograde Cholangio-pancreatography (ERCP) with aScope (Single use duodenoscope

ERCP Procedure will be done using aScope. We will assess the performance of the aScope.

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Suresh V Venkatachalapathy, MRCP · Nottingham University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2025-01-21
Completion
2025-03-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225909 on ClinicalTrials.gov