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Narrow Versus Wide Focal Zones for Shock Wave Lithotripsy of Renal Calculi

NCT ID: NCT01226875

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-04-30

Brief Summary

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Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL energy is focused on in order to break kidney stones and this energy can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. This is a multi-centered, randomized study comparing the single treatment success rates of narrow and wide focal zones during SWL.

Detailed Description

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Shock wave lithotripsy (SWL) is a safe and non-invasive treatment for kidney stones. The SWL machine that is currently in use has a unique feature: the focal zone or the energy that the SWL energy is focused on in order to break kidney stones can be varied in size from a narrow (or small) focal zone to a wide (or large) focal zone. Previous lithotripters have only offered one focal size that corresponded to a narrow range. The objective of this study is to compare the single-treatment success rates of narrow and wide focal zones for the shock wave lithotripsy of renal stones between 5 and 15 mm in greatest diameter, while maintaining a constant overall lithotripsy energy level. A wide focal zone may offer some trade-offs when compared with the traditional narrow focal zone: since the area being treated is larger, it is more likely that the stone will receive adequate energy as it moves with patient breathing during treatment, and less energy per cubic inch will be delivered to the kidney around the stone (which might lead to a lower degree of renal injury); on the other hand less energy per cubic inch will also be delivered to the stone, so that stone fragmentation might be inferior to that with a narrow focal zone. Thus, with this study we want to determine whether there is a significant difference in both stone fragmentation and in renal injury (as measured by the incidence of post-treatment renal hematoma or bruises, and by measuring urinary markers indicating the degree of renal cellular damage). Aside from the random choice of focal zone size, there will be no change to the standard of care for lithotripsy treatment. We predict that the narrow focal shock zone will result in superior stone fragmentation, with higher single-treatment stone free and success rates. However, we may identify a slight increased incidence in the rate of subcapsular renal hematoma and renal damage, as detected by urinary markers.

Conditions

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Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A (Narrow focus, LP)

A (Narrow focus): stone is in lower pole of kidney and SWL using narrow focus on lithotripter

Group Type ACTIVE_COMPARATOR

SWL: Shock Wave Lithotripsy Intervention

Intervention Type PROCEDURE

Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.

B (Wide focus, LP)

B: stone is in lower pole of kidney and SWL using wide focus on lithotripter

Group Type ACTIVE_COMPARATOR

SWL: Shock Wave Lithotripsy Intervention

Intervention Type PROCEDURE

Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.

C (Narrow focus, no LP)

C: stone is in no-lower pole of kidney and SWL using narrow focus on lithotripter

Group Type ACTIVE_COMPARATOR

SWL: Shock Wave Lithotripsy Intervention

Intervention Type PROCEDURE

Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.

D (Wide focus, no LP)

D: stone is in no-lower pole of kidney and SWL using wide focus on lithotripter

Group Type ACTIVE_COMPARATOR

SWL: Shock Wave Lithotripsy Intervention

Intervention Type PROCEDURE

Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.

Interventions

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SWL: Shock Wave Lithotripsy Intervention

Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Stone must be radiopaque on a KUB (kidney, ureter and bladder) radiograph, and located within the renal collecting system.
* Patients must have had a CT scan within the past 30 days.
* Stones must be solitary, between 5 and 15 mm in maximal diameter.
* Patient must consent to the trial and be willing to return to their respective lithotripsy unit at 2 weeks and 3 months for follow-up.
* Patients must be treated on the Storz Modulith SLX-F2 machine

Exclusion Criteria

* More than one renal calculus on the treated side.
* Radiolucent stones (uric acid, indinavir) or cystine stones.
* Stone size \< 5 mm and \> 15 mm.
* Previous surgical intervention on upper tracts within past five years.
* Congenital anatomic anomalies of the kidney, ureters or bladder (such as calyceal diverticulum, horseshoe kidney, etc.)
* Patient currently taking an α-blocker (alfuzosin, terazosin, doxazosin, tamsulosin, prazosin), calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine, bepridil, mibefradil), or corticosteroids.
* Pregnancy.
* Age \< 18 years.
* Active urinary tract infection.
* Patient exceed weight limit for SWL table (\>500 lbs)
* Previous SWL treatment for this stone.
* Uncorrected coagulopathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Honey, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto

Ken Pace, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto

Ben Chew, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia - Vancouver Coastal Health Research Institute

Ryan Paterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia - Vancouver Coastal Health Research Institute

Hassan Razvi, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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Vancouver General Hospital, Jim Pattison Pavilion G floor station 5 GI/GU Lithotripsy suite

Vancouver, British Columbia, Canada

Site Status

St. Joseph's Hospital, University of Western Ontario

London, Ontario, Canada

Site Status

St. Michael's Hospital, University of Toronto, Toronto, Lithotripsy suite, 5th floor Cardinal Carter North Wing

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10-225

Identifier Type: -

Identifier Source: org_study_id