ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi

The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. We hypothesize that the Trilogy will increase the stone clearance rate by 25% compared to the Shockpulse-SE

Large and complex renal calculi, defined as those with a maximum diameter of ≥ 1.5 cm, can be removed from the upper urinary tract by percutaneous nephrolithotomy but the stones usually require fragmentation in order to remove them through the access site. There are a number of commercially available intracorporeal lithotripters used to fragment or break kidney stones to allow elimination including pneumatic, ultrasonic, and combination devices. Each technology has its own relative advantages and disadvantages.

New versions of intracorporeal lithotripter devices have been introduced with improvements meant to address prior functional limitations such as probe clogging or breaking and cumbersome hand piece design.

The Trilogy lithotrite is the newest generation device stone fragmentation device from Boston Scientific. The Trilogy device uses unique technology to efficiently fragment and remove stone material, superior to other devices on the market based on preliminary bench testing. From Olympus, the ShockPulse-SE Lithotripsy System (Cybersonics, Erie, PA, USA) is a constant ultrasonic wave energy lithotripter with intermittent shock wave (ballistic/mechanical) energy. The ShockPulse-SE has a single probe design with an OD of 3.76 mm which allows for larger sized stone fragments to be vacuumed from the urothelium. The larger, single lumen also allows for a high flow rate to reduce probe clogging events. The end result is faster stone clearance rates based on in vitro studies.

The objective of this study is to compare the performance, as measured by the stone clearance rate at time of percutaneous nephrolithotomy, of the ShockPulse-SE Lithotripsy System to the Trilogy lithotrite when used for large complex renal calculi.

The Trilogy has been FDA cleared for fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Trilogy is a combined piezoelectric/pneumatic device capable of fragmenting calculi and aspirating stone debris. The novel technology in Trilogy has been demonstrated in bench testing to more quickly disintegrate stones compared to other devices.

The ShockPulse-SE Lithotripsy System has been FDA cleared fragmentation of urinary tract calculi in the kidney, ureter, and bladder. The ShockPulse-SE System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy which quickly disintegrates stones.

Study Objectives To compare the performance, as measured by the stone clearance rate at time of percutaneous nephrolithotomy, of the ShockPulse-SE Lithotripsy System to the Trilogy Lithotrite.

Study Endpoints Primary Endpoint Stone clearance rate defined as the kidney stone surface area measured by preoperative computed tomography (CT) scan divided by the time to remove the targeted stone burden.

Time to remove the targeted stone burden is measured at time the lithotripter unit starts fragmenting the stone to time all fragments are removed from the kidney based on visual inspection. This is prior to final visual inspection of the kidney with a flexible nephroscope.

Additional Endpoints

1. Device malfunctions
2. All complications measured by the Clavien Classification of Surgical Complications Stone free status as defined by the presence or absence of stone material on postoperative day 1 CT imaging This study is a post-market, prospective, randomized, multicenter, 2-arm, comparative trial.

Scale and Duration A total of 100 participants will be enrolled and treated at 4 study sites (3 USA, 1 Canada). Two sites will enroll 16 participants and 2 will enroll at least 18 participants. Each subject will be followed for approximately 6-12 weeks after the study procedure. It is anticipated for the entire study to last approximately 12 months.

Treatment Assignment The participants will be block randomized 1:1 to either stone removal with the Trilogy or the ShockPulse-SE device. All randomization will occur at the central study site via computer randomization by the statistician to limit selection bias.

Justification for the Study Design This study will compare performance of two devices for the treatment of large renal calculi. The study has been designed as a prospective, multi-centric, randomized, comparative study. The intent of this design is to minimize bias and to allow for statistical comparison of the two treatment groups.

Point of Enrollment A participant will be considered enrolled in the study if they meet all eligibility criteria and after the participant signs and dates the informed consent form (ICF). No study-related procedures can take placed until the ICF is signed.

Withdrawal All participants enrolled in the clinical study (including those withdrawn from the clinical study or lost to follow-up) shall be accounted for and documented. If a participant withdraws from the clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems related to study device safety or performance, the investigator shall ask for the participant's permission to follow his/her status/condition outside of the clinical study.

Reasons for withdrawal include:

* Physician discretion
* Participant choice to withdraw consent
* Lost to follow-up
* If the participant dies due to any cause

While study withdrawal is discouraged, participants may withdraw from the study at any time, with or without reason, and without prejudice to further treatment.

If any treated study patient is unable to return to the study center after treatment, efforts will be made to obtain complete follow-up information from the patient's primary physician. The reason for a patient's failure to return for the necessary follow-up visits or for a patient's discontinuance from the study must be determined and recorded in the case report forms (CRF).

All applicable CRFs up to the point of participant withdrawal must be completed. Participants who are "lost to follow up" should have documented attempts to contact them.

Additional data may no longer be collected after the point at which a participant has been withdrawn from the study or withdraws his/her consent, for whatever reason. Data collected up to the point of participant withdrawal may be used for study analysis.

Informed Consent All participants taking part in this clinical study must undergo the informed consent process. Participants must be allowed adequate time to review the consent, raise questions, and make a voluntary decision to participate in the clinical study. Each participant must sign and date the IRB approved informed consent form before any clinical study-related procedures are performed. A copy of signed informed consent form will be provided to the participant for his/her records. A participant's participation in the clinical study begins with the signing and dating of the informed consent form.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. At least one renal stone \> 1.5 cm in maximum diameter as measured on preoperative CT scan
3. Patient is scheduled to undergo a percutaneous nephrolithotomy procedure
4. Willing and able to provide informed consent

Exclusion Criteria:

1. Pregnant
2. Active urinary tract infection
3. Prior shock wave lithotripsy within 3 months of study procedure
4. Multiple percutaneous access sites are anticipated
5. Unable or unwilling to provide informed consent -