Efficacy and Safety of Narrow Focus (F1) Versus Wide Focus (F3) of Shock Wave Lithotripsy (SWL) for Renal Calculi
NCT ID: NCT04759599
Last Updated: 2023-08-01
Study Results
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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UNKNOWN
NA
140 participants
INTERVENTIONAL
2021-02-01
2023-09-30
Brief Summary
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Detailed Description
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The SWL device:
Lithotripter type: Piezo Lith3000 plus ( from Richard Wolf, Germany.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
Group 1 will undergo Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks
Shock Wave Lithotripsy (SWL)
Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks or Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
Group 2
Group 2 will undergo Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
Shock Wave Lithotripsy (SWL)
Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks or Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
Interventions
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Shock Wave Lithotripsy (SWL)
Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks or Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
Eligibility Criteria
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Inclusion Criteria
2. Normal functioning kidney.
Exclusion Criteria
2. Bleeding diatheses.
3. Radiolucent stones.
4. Radio-opaque stones with Hounsfield Unit (HU) \> 1200
5. Patients with a pacemaker.
6. Active Urinary Tract Infection (UTI).
7. Severe skeletal malformations.
8. Morbid obesity with Body Mass Index (BMI) ≥40 kg/m2.
9. Renal artery aneurysm at the same site of the stone.
10. Anatomical obstruction distal to the stone.
11. Patients with renal impairment with serum creatinine \> 1.2 mg/dL.
18 Years
ALL
Yes
Sponsors
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Benha University
OTHER
Responsible Party
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Yasser A. Noureldin
Assistant Professor of Urology
Principal Investigators
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Yasser Noureldin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Benha University
Ahmed Abdelbaky, MD, PhD
Role: STUDY_CHAIR
Benha University
Walid Ibrahim, MD, PhD
Role: STUDY_DIRECTOR
Benha University
Ezzat Elnahife, MD
Role: STUDY_DIRECTOR
Benha University
Salah El Hamshary, MD, PhD
Role: STUDY_DIRECTOR
Benha University
Locations
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Faculty of Medicine, Benha University
Banhā, Kalyobiya, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Turney BW, Reynard JM, Noble JG, Keoghane SR. Trends in urological stone disease. BJU Int. 2012 Apr;109(7):1082-7. doi: 10.1111/j.1464-410X.2011.10495.x. Epub 2011 Aug 26.
Connors BA, Evan AP, Blomgren PM, Handa RK, Willis LR, Gao S. Effect of initial shock wave voltage on shock wave lithotripsy-induced lesion size during step-wise voltage ramping. BJU Int. 2009 Jan;103(1):104-7. doi: 10.1111/j.1464-410X.2008.07922.x. Epub 2008 Aug 1.
Devarajan P. Biomarkers for the early detection of acute kidney injury. Curr Opin Pediatr. 2011 Apr;23(2):194-200. doi: 10.1097/MOP.0b013e328343f4dd.
Veser J, Jahrreiss V, Seitz C, Ozsoy M. The effect of focus size and intensity on stone fragmentation in SWL on a piezoelectric lithotripter. World J Urol. 2020 Oct;38(10):2645-2650. doi: 10.1007/s00345-019-03069-y. Epub 2020 Jan 10.
Other Identifiers
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MD 1-11-2020
Identifier Type: -
Identifier Source: org_study_id
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