Comparison of Lithotripsy Urolithiasis Machines

Not Applicable

Completed

• Conditions: Kidney Calculi; Ureteral Calculi; Ureterolithiasis; Urolithiasis; Kidney Stone
• Interventions: Procedure: Lithotripter

• Registration Number: NCT04069338
• Lead Sponsor: The Cleveland Clinic

Brief Summary

A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.

Detailed Description

This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.

Study Timeline

• Study Start: 2019-05-31
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Primary Completion: 2022-10-12
• Study Completion: 2022-10-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed

• Age ≥ 18 years old
• Male and female patients
• Patients of all ethnic backgrounds
• Stone size 5-15mm
• Stone location: Renal or proximal ureter
• Stone density: < 1200 Hounsfield Units
• Skin to stone distance: < 12cm
• Primary treatment for a solitary stone (must be previously untreated)

Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.

Exclusion Criteria

• Prior treatment for specified stone

  • Multiple stones on treatment side (even if only one is treated)
  • Anticoagulated or history of coagulopathy
  • Prior ureteral stent placement
  • Technical problems/impossibility of localizing the stone on the day of intervention

Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dornier Delta III Treatment	Lithotripter	Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
Device Storz Modulith SLX-F2	Lithotripter	Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2

Primary Outcome Measures

Name	Time	Method
Stone free rate	Four weeks post operative	Presence of stone on follow up imaging

Secondary Outcome Measures

Name	Time	Method
Secondary Interventions required	One month post-operative	Follow up surgery
Fluoroscopy time	Intra-operative	Length of fluoroscopy exposure
Pain Scores	Four days post-operative	Response to visual analog scale
Treatment Time	Intra-operative	Length of surgical procedure
Complication Rates	One month post-operative	Medical complications

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States