NCT03763539

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

December 1, 2018

Last Update Submit

December 3, 2018

Conditions

Renal Stones

Keywords

renal stonesSWLHigh density stonesUltraslow SWLSlow SWLRampingPause

Outcome Measures

Primary Outcomes (1)

  • stone free rate

    Complete clearance of stones in addition to clinically insignificant residual fragments

    3 months following last session of SWL

Secondary Outcomes (1)

  • Complications

    1 year following last session of SWL

Study Arms (2)

Ultraslow shock wave lithotripsy (SWL)

ACTIVE COMPARATOR

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).

Procedure: SWL

Slow power-ramping SWL

ACTIVE COMPARATOR

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.

Procedure: SWL

Interventions

SWLPROCEDURE

Shock wave lithotripsy

Also known as: ESWL
Slow power-ramping SWLUltraslow shock wave lithotripsy (SWL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef Hospitals

Banī Suwayf, Outside U.S./Canada, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Ahmad Aref Al-Dessoukey, Ass. Prof.

    Beni-Suef University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Urology

Study Record Dates

First Submitted

December 1, 2018

First Posted

December 4, 2018

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)