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Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value (SWL)

Primary Purpose

Renal Stones

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SWL
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stones focused on measuring renal stones, SWL, High density stones, Ultraslow SWL, Slow SWL, Ramping, Pause

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
  • radio-opaque stone
  • high attenuation value (≥ 1000 HU) stone

Exclusion Criteria:

  • Abnormal renal anatomy
  • renal insufficiency
  • solitary kidney
  • coagulopathies
  • uncontrolled hypertension
  • renal artery or aortic aneurysm
  • active urinary tract infection
  • pregnancy
  • severe skeletal malformations (spinal deformity) precluding proper stone localization
  • skin to stone distance (SSD) > 11 cm
  • BMI > 30 Kgm/m2

Sites / Locations

  • Beni-Suef Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultraslow shock wave lithotripsy (SWL)

Slow power-ramping SWL

Arm Description

SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power).

SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.

Outcomes

Primary Outcome Measures

stone free rate
Complete clearance of stones in addition to clinically insignificant residual fragments

Secondary Outcome Measures

Complications
Comparison of complications in both groups

Full Information

First Posted
December 1, 2018
Last Updated
December 3, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03763539
Brief Title
Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
Acronym
SWL
Official Title
Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value
Detailed Description
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stones
Keywords
renal stones, SWL, High density stones, Ultraslow SWL, Slow SWL, Ramping, Pause

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultraslow shock wave lithotripsy (SWL)
Arm Type
Active Comparator
Arm Description
SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power).
Arm Title
Slow power-ramping SWL
Arm Type
Active Comparator
Arm Description
SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.
Intervention Type
Procedure
Intervention Name(s)
SWL
Other Intervention Name(s)
ESWL
Intervention Description
Shock wave lithotripsy
Primary Outcome Measure Information:
Title
stone free rate
Description
Complete clearance of stones in addition to clinically insignificant residual fragments
Time Frame
3 months following last session of SWL
Secondary Outcome Measure Information:
Title
Complications
Description
Comparison of complications in both groups
Time Frame
1 year following last session of SWL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones) radio-opaque stone high attenuation value (≥ 1000 HU) stone Exclusion Criteria: Abnormal renal anatomy renal insufficiency solitary kidney coagulopathies uncontrolled hypertension renal artery or aortic aneurysm active urinary tract infection pregnancy severe skeletal malformations (spinal deformity) precluding proper stone localization skin to stone distance (SSD) > 11 cm BMI > 30 Kgm/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Aref Al-Dessoukey, Ass. Prof.
Organizational Affiliation
Beni-Suef University
Official's Role
Study Director
Facility Information:
Facility Name
Beni-Suef Hospitals
City
Banī Suwayf
State/Province
Outside U.S./Canada
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value

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