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

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ClinicalTrials.gov Identifier: NCT03959683
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Boston Scientific Corporation
Ohio State University
Mayo Clinic
University of British Columbia
Information provided by (Responsible Party):
Amy Krambeck, MD, Indiana University

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

Condition or disease Intervention/treatment Phase
Kidney Calculi Device: Trilogy Lithotrite Device: The ShockPulse-SE Lithotripsy System Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, multicenter, 2 arm, comparative trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Trial Comparing Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: Trilogy device
Trilogy Lithotrite to fragment urinary tract calculi in the kidney, ureter and bladder
Device: Trilogy Lithotrite
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.

Active Comparator: ShockPulse-SE
ShockPulse-SE Lithotripsy System to fragment urinary calculi in the kidney, ureter and bladder
Device: The ShockPulse-SE Lithotripsy System
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.




Primary Outcome Measures :
  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 Frame: Postoperative day 1 ]
    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.


Secondary Outcome Measures :
  1. Device malfunctions during intraoperative device use as described by surgeon completing the device questionnaire. [ Time Frame: any malfunctions during intraoperative device use ]
    any malfunctions during intraoperative device use

  2. All complications measured by the Clavien Classification of Surgical Complications [ Time Frame: Intraoperative ]
    Complications as measured by the Clavien Classification of Surgical Complications

  3. Stone free status as defined by the presence or absence of stone material on postoperative CT imaging and at final follow up [ Time Frame: postoperative day 1 ]
    Stone free status must be assessed postoperative day 1 by CT scan.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959683


Contacts
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Contact: Amy E Krambeck, MD 3179623700 akrambeck@iuhealth.org
Contact: Christa E Stoughton, BS 3179620870 cstoughton@iuhealth.org

Locations
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United States, Arizona
Mayo Clinic Hospital Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Mitchell Humphreys, MD    480-342-2951    Humphreys.Mitchell@mayo.edu   
Contact: Vy Nguyen    4803421328    nguyen.vy@mayo.edu   
United States, Indiana
Indiana University Health Physicians Urology Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Amy E Krambeck, MD    317-962-3700    akrambeck@iuhealth.org   
Contact: Christa E Stoughton    3179620870    cstoughton@iuhealth.org   
United States, Ohio
The Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43212
Contact: Michael Sourial, MD    614-293-8000    michael.sourial@osumc.edu   
Contact: Alicia Scimeca    6146856667    alicia.scimeca@osumc.edu   
Canada, British Columbia
The University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Ben Chew, MD    6048754111 ext 62421    ben.chew@ubc.ca   
Contact: Victor Wong    6048754111 ext 62421    kfvwong@alumni.ubc.ca   
Sponsors and Collaborators
Indiana University
Boston Scientific Corporation
Ohio State University
Mayo Clinic
University of British Columbia
Investigators
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Principal Investigator: Amy E Krambeck, MD Indiana University Health

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Responsible Party: Amy Krambeck, MD, Michael O. Koch Professor of Urology, Indiana University
ClinicalTrials.gov Identifier: NCT03959683     History of Changes
Other Study ID Numbers: 1803658961
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi