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Laser vs. shock wave: which breaks tough stones better?

NCT ID NCT07418112

Symptom relief Sponsor: Rush University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two devices used during an ERCP procedure to break up large or stuck stones in the bile or pancreatic ducts. Forty adults will be randomly assigned to receive either low-power holmium laser lithotripsy or electrohydraulic lithotripsy. The main goal is to see which method clears the stones more completely in one session, and to check for side effects over 30 days.

What this could mean

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

Active substance
holmium laser lithotripsy device
What this could lead to
If successful, this could show that a low-power laser is a safer or more effective way to break up large bile or pancreatic duct stones compared to the standard shock-wave method.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. Both procedures carry risks like bleeding or infection, and the laser may not work better than the current approach.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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

19 to 85 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: * Age 19-85 years * Signed written informed consent. * Presence of one or more biliary (common bile duct or intrahepatic) or pancreatic duct stones that are deemed "difficult" based on at least one of the following criteria: * Stone diameter ≥ 15 mm in any single dimension as measured on prior cross-sectional imaging (CT, MRCP, or EUS). * Presence of an impacted stone that cannot be dislodged with a standard balloon or basket. * Stone located proximal to a benign biliary or pancreatic duct stricture. * Documented failure of stone extraction during a prior ERCP attempt using standard techniques (e.g., sphincterotomy with balloon/basket extraction). Exclusion Criteria: * Pregnancy: Repeated ERCP would be delayed until after delivery if possible * Clinically significant, uncorrectable coagulopathy (defined as INR \> 1.5 or platelet count \< 50,000/μL). * Surgically altered upper gastrointestinal anatomy that precludes conventional ERCP access (e.g., Roux-en-Y gastric bypass), unless an alternative access route (e.g., laparoscopy-assisted or EUS-directed) is planned as the standard of care. * Known or highly suspected malignant biliary or pancreatic stricture associated with the stone. * Acute pancreatitis at the time of screening, unless it is gallstone pancreatitis with persistent biliary obstruction, for which ERCP is therapeutically indicated. * Severe cardiopulmonary disease or other comorbidities that, in the judgment of the investigator, would make the patient an unsuitable candidate for a prolonged endoscopic procedure under general anesthesia. * Known life expectancy of less than 6 months. * Inability or unwillingness to comply with study procedures or follow-up requirements.

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Conditions

The condition(s) this trial relates to.

choledocholithiasis

As listed by the trial registrant

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

Choledocholithiasis Pancreatic duct stone

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

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