Trial Outcomes & Findings for ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi (NCT NCT03959683)

Last Updated: 2023-04-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

Postoperative day 1

Results posted on

2023-04-12

Participant Flow

Intention to treat - there was one patient that was recruited to the wrong arm but was maintained in that arm - and there was complete follow up with out any cross-over.

Participant milestones

Participant milestones
Measure	ShockPulse Intervention Arm This represents patient who underwent PCNL with the ShockPulse Lithotripter	Trilogy Intervention Arm This represents patient who underwent PCNL with the Trilogy Lithotripter
Overall Study STARTED	49	51
Overall Study COMPLETED	49	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trilogy Device n=51 Participants Trilogy Lithotrite to fragment urinary tract calculi in the kidney, ureter and bladder 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.	ShockPulse-SE n=49 Participants ShockPulse-SE Lithotripsy System to fragment urinary calculi in the kidney, ureter and bladder 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.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=51 Participants	0 Participants n=49 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=51 Participants	49 Participants n=49 Participants	100 Participants n=100 Participants
Age, Categorical >=65 years	0 Participants n=51 Participants	0 Participants n=49 Participants	0 Participants n=100 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 14.8 • n=51 Participants	60.4 years STANDARD_DEVIATION 16.2 • n=49 Participants	60.1 years STANDARD_DEVIATION 15.8 • n=100 Participants
Sex: Female, Male Female	31 Participants n=51 Participants	24 Participants n=49 Participants	55 Participants n=100 Participants
Sex: Female, Male Male	20 Participants n=51 Participants	25 Participants n=49 Participants	45 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	51 participants n=51 Participants	49 participants n=49 Participants	100 participants n=100 Participants
Body Mass Index	33.4 kg/m^2 STANDARD_DEVIATION 12.3 • n=51 Participants	32.5 kg/m^2 STANDARD_DEVIATION 10.1 • n=49 Participants	32.9 kg/m^2 STANDARD_DEVIATION 11.2 • n=100 Participants
Prior Kidney Stone Surgery	21 Participants n=51 Participants	22 Participants n=49 Participants	43 Participants n=100 Participants
Surgery Study Side (Right)	23 Participants n=51 Participants	23 Participants n=49 Participants	46 Participants n=100 Participants
Partial or Complete Staghorn	22 Participants n=51 Participants	26 Participants n=49 Participants	48 Participants n=100 Participants
Total number of Discrete stones	2.39 stones STANDARD_DEVIATION 1.74 • n=51 Participants	2.94 stones STANDARD_DEVIATION 2.09 • n=49 Participants	2.67 stones STANDARD_DEVIATION 1.92 • n=100 Participants
Maximum Stone Diameter	23.2 mm STANDARD_DEVIATION 13.1 • n=51 Participants	25.3 mm STANDARD_DEVIATION 10.8 • n=49 Participants	24.3 mm STANDARD_DEVIATION 11 • n=100 Participants
Target Stone Hounsfield Units	927 HU STANDARD_DEVIATION 386 • n=51 Participants	933 HU STANDARD_DEVIATION 410 • n=49 Participants	930 HU STANDARD_DEVIATION 796 • n=100 Participants
Target Stone Surface Area	351.3 mm^2 STANDARD_DEVIATION 277.7 • n=51 Participants	375.3 mm^2 STANDARD_DEVIATION 228.8 • n=49 Participants	363.3 mm^2 STANDARD_DEVIATION 114.5 • n=100 Participants
Target Stone Volume	4.2 cm^3 STANDARD_DEVIATION 4.8 • n=51 Participants	3.9 cm^3 STANDARD_DEVIATION 3.4 • n=49 Participants	4.1 cm^3 STANDARD_DEVIATION 4.1 • n=100 Participants

PRIMARY outcome

Timeframe: Postoperative day 1

Outcome measures

Outcome measures
Measure	ShockPulse Intervention Arm n=49 Participants This represents patient who underwent PCNL with the ShockPulse Lithotripter	Trilogy Intervention Arm n=51 Participants This represents patient who underwent PCNL with the Trilogy Lithotripter
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.	1.22 cm^3/min Standard Deviation 1.67	0.77 cm^3/min Standard Deviation 0.68

SECONDARY outcome

Timeframe: any malfunctions during intraoperative device use

any malfunctions during intraoperative device use

Outcome measures

Outcome measures
Measure	ShockPulse Intervention Arm n=51 Participants This represents patient who underwent PCNL with the ShockPulse Lithotripter	Trilogy Intervention Arm n=49 Participants This represents patient who underwent PCNL with the Trilogy Lithotripter
Device Malfunctions During Intraoperative Device Use as Described by Surgeon Completing the Device Questionnaire.	1 malfunction events	17 malfunction events

SECONDARY outcome

Timeframe: 90 days

Clavien Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Acceptable therapeutic regiments are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside. Clavien Grade II: Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Clavien Grade III: Requiring surgical, endoscopic or radiological intervention

Outcome measures

Outcome measures
Measure	ShockPulse Intervention Arm n=51 Participants This represents patient who underwent PCNL with the ShockPulse Lithotripter	Trilogy Intervention Arm n=49 Participants This represents patient who underwent PCNL with the Trilogy Lithotripter
All Complications Measured by the Clavien Classification of Surgical Complications Clavien I	1 complications	5 complications
All Complications Measured by the Clavien Classification of Surgical Complications Clavien II	2 complications	3 complications
All Complications Measured by the Clavien Classification of Surgical Complications Clavien III	3 complications	1 complications

SECONDARY outcome

Timeframe: postoperative day 1

Stone free status must be assessed postoperative day 1 by CT scan.

Outcome measures

Outcome measures
Measure	ShockPulse Intervention Arm n=51 Participants This represents patient who underwent PCNL with the ShockPulse Lithotripter	Trilogy Intervention Arm n=49 Participants This represents patient who underwent PCNL with the Trilogy Lithotripter
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	46 Participants	44 Participants

Adverse Events

Trilogy Device

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

ShockPulse-SE

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Trilogy Device n=51 participants at risk Trilogy Lithotrite to fragment urinary tract calculi in the kidney, ureter and bladder 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.	ShockPulse-SE n=49 participants at risk ShockPulse-SE Lithotripsy System to fragment urinary calculi in the kidney, ureter and bladder 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.
Blood and lymphatic system disorders Hematuria	2.0% 1/51 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.	2.0% 1/49 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.
Injury, poisoning and procedural complications Hemothorax	2.0% 1/51 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.	0.00% 0/49 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.
Infections and infestations Intesive Care Unit Admission	2.0% 1/51 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.	2.0% 1/49 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.
Injury, poisoning and procedural complications Retrograde Stent Placement	2.0% 1/51 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.	0.00% 0/49 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.
Gastrointestinal disorders Gastrointestinal Bleeding	2.0% 1/51 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.	2.0% 1/49 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.
Infections and infestations Urinary Tract Infection	2.0% 1/51 • Number of events 1 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.	4.1% 2/49 • Number of events 2 • Monitoring of adverse events occurred throughout the trial period and 90 days after surgery.

Additional Information

Erica Sahm

INDIANA UNI SCHOOL OF MEDICINE

Phone: 317-274-3560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place