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

NCT03959683 | Completed Results DMC FDA Device

• 1 other identifier: 1803658961
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• Stone Clearance Rate Defined as the Kidney Stone Surface Area Measured by Pre-operative 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.

  Postoperative day 1

Secondary Outcomes (3)

• Device Malfunctions During Intraoperative Device Use as Described by Surgeon Completing the Device Questionnaire.

  any malfunctions during intraoperative device use

• All Complications Measured by the Clavien Classification of Surgical Complications

  90 days

• Number of Participants With Stone Free Status as Defined by the Presence or Absence of Stone Material on Postoperative CT Imaging and at Final Follow up

  postoperative day 1

Study Arms (2)

Trilogy device

ACTIVE COMPARATOR

Trilogy Lithotrite to fragment urinary tract calculi in the kidney, ureter and bladder

Device: Trilogy Lithotrite

ShockPulse-SE

ACTIVE COMPARATOR

ShockPulse-SE Lithotripsy System to fragment urinary calculi in the kidney, ureter and bladder

Device: The ShockPulse-SE Lithotripsy System

Interventions

Trilogy Lithotrite DEVICE

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.

Trilogy device

The ShockPulse-SE Lithotripsy System DEVICE

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.

ShockPulse-SE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Boston Scientific Corporation: collaborator
• Ohio State University: collaborator
• Mayo Clinic: collaborator
• University of British Columbia: collaborator

Study Sites (4)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Indiana University Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

The Ohio State University

Columbus, Ohio, 43212, United States

Location

The University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

• Large T, Nottingham C, Brinkman E, Agarwal D, Ferrero A, Sourial M, Stern K, Rivera M, Knudsen B, Humphreys M, Krambeck A. Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial. J Endourol. 2021 Sep;35(9):1326-1332. doi: 10.1089/end.2020.1097. Epub 2021 Aug 16.

  PMID: 33843245 DERIVED

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Erica Sahm
• Organization: INDIANA UNI SCHOOL OF MEDICINE

esahm@iuhealth.org

317-274-3560

Study Officials

• Amy E Krambeck, MD

  Indiana University Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Urology

Model Details: Prospective, randomized, multicenter, 2 arm, comparative trial

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 22, 2019
• Study Start: February 19, 2019
• Primary Completion: July 29, 2020
• Study Completion: November 18, 2020
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (3)