CoLUM: Comparison of Lithotripsy Urolithiasis Machines

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04069338

Collaborator

(none)

162

Enrollment

Location

Arms

52.7

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone Kidney Calculi Ureteral Calculi Ureterolithiasis Urolithiasis	Procedure: Lithotripter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines

Actual Study Start Date :

May 31, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Oct 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Device Storz Modulith SLX-F2 Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2	Procedure: Lithotripter Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Active Comparator: Dornier Delta III Treatment Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter	Procedure: Lithotripter Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines

Arm

Intervention/Treatment

Active Comparator: Device Storz Modulith SLX-F2

Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2

Procedure: Lithotripter

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

Active Comparator: Dornier Delta III Treatment

Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter

Procedure: Lithotripter

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

Outcome Measures

Primary Outcome Measures

Stone free rate [Four weeks post operative]
Presence of stone on follow up imaging

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.