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

NCT01226875 | Completed

• 1 other identifier: 10-225
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Kidney Stones

Keywords

SWL; kidney stones; renal calculi

Outcome Measures

Primary Outcomes (1)

• SWL efficiency quotient comparison between narrow focus vs wide focus

  Comparison of single-treatment lithotripsy success rates at 2 and 12 weeks post-lithotripsy. Successful treatment will be defined as either stone-free status or presence of clinically insignificant asymptomatic residual fragments ≤ 4 mm. SWL efficiency quotient for the treatment groups, as calculated by the standardized formula: % stone-free divided by (100 + % re-treated + % auxiliary procedures).

  2 and 12 weeks

Secondary Outcomes (5)

• Incidence of perirenal hematomas

  post treatment

• Biomarkers for renal injury

  day 0; day 1; 1 week

• Time to stone passage

  12 weeks

• Pain will be compared between narrow vs wide focus arms

  day 0 (post treatment)

• Complication rates

  12 weeks

Study Arms (4)

A (Narrow focus, LP)

ACTIVE COMPARATOR

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

Procedure: SWL: Shock Wave Lithotripsy Intervention

B (Wide focus, LP)

ACTIVE COMPARATOR

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

Procedure: SWL: Shock Wave Lithotripsy Intervention

C (Narrow focus, no LP)

ACTIVE COMPARATOR

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

Procedure: SWL: Shock Wave Lithotripsy Intervention

D (Wide focus, no LP)

ACTIVE COMPARATOR

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

Procedure: SWL: Shock Wave Lithotripsy Intervention

Interventions

SWL: Shock Wave Lithotripsy Intervention 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.

A (Narrow focus, LP); B (Wide focus, LP); C (Narrow focus, no LP); D (Wide focus, no LP)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator
• University of Western Ontario, Canada: collaborator
• University of British Columbia: collaborator

Study Sites (3)

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

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Joseph's Hospital, University of Western Ontario

London, Ontario, Canada

Location

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

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Officials

• John Honey, MD

  St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

• Ken Pace, MD

  St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

• Ben Chew, MD

  University of British Columbia - Vancouver Coastal Health Research Institute

  PRINCIPAL INVESTIGATOR

• Ryan Paterson, MD

  University of British Columbia - Vancouver Coastal Health Research Institute

  PRINCIPAL INVESTIGATOR

• Hassan Razvi, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 22, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

CA (3)