Back to results

Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value (ESWL)

Primary Purpose

Renal Stones

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

SWL

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 HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

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 rate

Comparison of rate of complications in both groups

Full Information

NCT ID

NCT03795532

First Posted

January 4, 2019

Last Updated

January 20, 2019

Sponsor

Cairo University

Collaborators

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT03795532

Brief Title

Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value

Acronym

ESWL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 11, 2019 (Actual)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Ultraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value

Detailed Description

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones

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

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultraslow shock wave lithotripsy (SWL)

Arm Type

Active Comparator

Arm Description

Arm Title

Slow power-ramping SWL

Arm Type

Active Comparator

Arm Description

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 rate

Description

Comparison of rate of complications in both groups

Time Frame

3 months following last session of SWL

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed S ElSheemy, Ass. Prof.

Phone

01006117755

mohammedshemy@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmad Aref Al-Dessoukey, Ass. Prof.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad Aref Al-Dessoukey

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

A AlDessoukey, Ass. Prof.

First Name & Middle Initial & Last Name & Degree

Mohammed S ElSheemy, A Professor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value

We'll reach out to this number within 24 hrs