Comparison of Lithotripsy Urolithiasis Machines

NCT04069338 | Completed

• 1 other identifier: 19-619
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Stone; Kidney Calculi; Ureteral Calculi; Ureterolithiasis; Urolithiasis

Keywords

Lithotripsy; Extracorporeal shockwave lithotripsy

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  Presence of stone on follow up imaging

  Four weeks post operative

Secondary Outcomes (5)

• Fluoroscopy time

  Intra-operative

• Treatment Time

  Intra-operative

• Pain Scores

  Four days post-operative

• Complication Rates

  One month post-operative

• Secondary Interventions required

  One month post-operative

Study Arms (2)

Device Storz Modulith SLX-F2

ACTIVE COMPARATOR

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

Procedure: Lithotripter

Dornier Delta III Treatment

ACTIVE COMPARATOR

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

Procedure: Lithotripter

Interventions

Lithotripter PROCEDURE

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

Device Storz Modulith SLX-F2; Dornier Delta III Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Ureteral Calculi; Ureterolithiasis; Urolithiasis

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases

Study Officials

• Manoj Monga, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: May 31, 2019
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)