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Disposable scope could cut infection risk in ERCP

NCT ID NCT05225909

Knowledge-focused Sponsor: Nottingham University Hospitals NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new single-use duodenoscope (aScope) in 59 patients at high risk of infection after ERCP, a procedure to treat bile duct problems. The goal was to see if the scope works well and to gather information on costs and complications. The results could help decide if single-use scopes are a good option to prevent infections from contaminated reusable scopes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
single-use duodenoscope (aScope)
What this could lead to
If successful, this could show that single-use scopes are a safe and effective option to reduce infection risk after ERCP.
What could go wrong
This is a small, observational study with only 59 participants, so results may not apply to all patients. It does not directly compare infection rates with reusable scopes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

59 people

The number who actually took part.

Started

Jul 2022

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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) * 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. Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

cholangitis Infections infectious disease primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholangitis ERCP Infection

Contacts and locations

Locations

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottingham, Ng7 2UH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.