A Phase 4 interventional study of Laser lithotripsy with low-wattage holmium laser and Electrohydraulic lithotripsy in Choledocholithiasis and Pancreatic Duct Stone, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn if a low-power holmium laser works to treat large and/or difficult bile duct or pancreatic duct stones in adults. It will also learn about the safety of the low-wattage holmium laser. The main questions it aims to answer are:
Is the low-power holmium laser effective at treating large and/or difficult bile duct or pancreatic duct stones? Is the low-power holmium laser effective safe to use in adults? How does the low-power holmium laser compare to electrohydraulic lithotripsy for the management of large and/or difficult bile duct or pancreatic duct stones.
Participants will:
Undergo ERCP procedure and their bile duct or pancreatic duct stone will either be broken up with the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy lithotripsy device.
Answer a call 30 days after the procedure to document symptoms and/or any side effects.
This study aims to assess two main questions. 1: Whether low-wattage holmium:YAG laser lithotripsy (using the Quanta System Litho EVO device) is safe and effective in the management large and/or difficult bile duct or pancreatic duct stones. 2: Whether low-wattage holmium:YAG laser lithotripsy is non-inferior to electrohydraulic lithotripsy in the management of large and/or difficult gallstones.
Part one of the study will investigate whether utilizing the low-wattage holmium:YAG laser lithotripsy device via single-operator cholangioscopy (SOC-LL) is safe and effective to treat large and/or difficult choledocholithiasis or pancreaticolithiasis.
Part two of the study will be a non-inferiority study to determine if SOC-LL is non-inferior for stone clearance, among other secondary outcomes, compared to electrohydraulic lithotripsy via single-operator cholangioscopy (SOC-EHL).
Patients who meet the inclusion criteria will undergo ERCP procedures and will either undergo SOC-LL or SOC-EHL to treat their large and/or difficult choledocholithiasis or pancreaticolithiasis. Stone clearance and other procedural or safety measures will be assessed after the procedure. The patient will be monitored after the procedure for adverse events and the administration of medications or admission to the hospital will be determined by the proceduralist. Roughly 30 days after the procedure the patient will be called to assess for any adverse effects as well as to determine symptom resolution.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Laser lithotripsy (LL). Use of LL to break down large/difficult bile duct or pancreatic duct stones.
Device: Laser lithotripsy with low-wattage holmium laser
Electrohydraulic lithotripsy (EHL). Use of EHL to break down large/difficult bile duct or pancreatic duct stones.
Device: Electrohydraulic lithotripsy
Use of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.
Also known as: laser lithotripsy, lithotripsy
Use of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.
Also known as: EHL
Complete stone clearance
Complete stone clearance is defined as the lithotripsy and clearance of ductal stone fragments as confirmed on cholangiogram or pancreaticogram at the end of the index/first procedure of the study.
Time frame: Immediately after the procedure
Overall complete stone clearance rate
This describes the rate of complete stone clearance at the end of the final procedure required to completely clear stones, regardless of the number of procedures required to do so.
Time frame: Immediately after the final procedure
Number of procedures
Describes the number of ERCP procedures required to achieve complete stone clearance.
Time frame: Immediately after the final procedure
Total procedure time
Total duration of index ERCP procedure. Will also document total procedural time for all necessary ERCPs to achieve stone clearance.
Time frame: Immediately after the final procedure
Total lithotripsy time
Duration of the activation time for either the laser lithotripsy or the electrohydraulic lithotripsy devices during the study duration.
Time frame: Immediately after the final procedure
Rate of rescue mechanical lithotripsy
Describes the percentage/rate of time that the patient requires rescue mechanical lithotripsy after failure of the primary modality (SOC-LL or SOC-EHL).
Time frame: Immediately after the final procedure
Length of post-procedure hospital stay
Describes the amount of time in days the patient spent in the hospital after any and all required procedures to achieve complete stone clearance.
Time frame: Immediately after the final procedure
Plan to share: No — Study will stay at Rush no plan for multiple centers.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
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