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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04069338
Other study ID # 19-619
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2019
Est. completion date October 12, 2022

Study information

Verified date December 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date October 12, 2022
Est. primary completion date October 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stone free rate Presence of stone on follow up imaging Four weeks post operative
Secondary Fluoroscopy time Length of fluoroscopy exposure Intra-operative
Secondary Treatment Time Length of surgical procedure Intra-operative
Secondary Pain Scores Response to visual analog scale Four days post-operative
Secondary Complication Rates Medical complications One month post-operative
Secondary Secondary Interventions required Follow up surgery One month post-operative
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