Comparison of Lithotripsy Urolithiasis Machines

The Cleveland Clinic6 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Kidney Stone Kidney Calculi Ureteral Calculi Ureterolithiasis Urolithiasis

Interventions

LithotripterPROCEDURE

Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Stone free rate

Presence of stone on follow up imaging

Time frame: Four weeks post operative

Secondary Outcomes

Fluoroscopy time

Length of fluoroscopy exposure

Time frame: Intra-operative

Treatment Time

Length of surgical procedure

Time frame: Intra-operative

Pain Scores

Response to visual analog scale

Time frame: Four days post-operative

Complication Rates

Medical complications

Time frame: One month post-operative

Secondary Interventions required

Follow up surgery

Time frame: One month post-operative

Data from ClinicalTrials.gov

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