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New disposable scope cover may lower infection risk in gut procedures

NCT ID NCT05429203

Disease control Sponsor: Stanford University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested two types of endoscopes used in ERCP, a procedure to treat bile duct and pancreas problems. One scope had a single-use plastic cover on its tip, while the other was a standard reusable scope. Researchers compared how well each worked and how often complications like infection or bleeding occurred. The trial included 319 adults and aimed to see if the disposable cover could make the procedure safer.

What this could mean

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

Active substance
Duodenoscope with single-use distal cover
What this could lead to
If successful, this could show that a single-use cover reduces infection risk during ERCP while maintaining procedure success.
What could go wrong
This is a completed device comparison, not a new treatment. The main benefit is infection control, not curing disease. Results may not apply to all patients or settings.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

319 people

The number who actually took part.

Started

Oct 2022

Finished

Jul 2024

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.

Ages

18 years and older

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 undergoing ERCP for biliary and pancreatic conditions * Age \> 18 years old Exclusion Criteria: * Vulnerable patient groups including pregnant women * Patients who are unable to consent * Patients with known cholangitis * Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection * Surgically altered anatomy except for Billroth I

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Conditions

The condition(s) this trial relates to.

biliary tract disorder biliary tract neoplasm Biliary Tract Neoplasms choledocholithiasis cholestasis gallbladder disorder pancreas disorder pancreatic neoplasm

As listed by the trial registrant

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

Biliary disease Biliary obstruction Biliary tract neoplasms Choledocholithiasis Pancreatic disease Pancreatic neoplasms

Contacts and locations

Locations

  • Stanford hospital

    Palo Alto, California, 943305, United States

More trials for these conditions

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