Comparison of Lithotripsy Urolithiasis Machines

Not Applicable

Completed

• Conditions: Kidney Calculi; Ureteral Calculi; Ureterolithiasis; Urolithiasis; Kidney Stone

• 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

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

Trial Locations

Locations (1)

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