NCT03795532

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

January 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

January 4, 2019

Last Update Submit

January 20, 2019

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 rate

    3 months 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

RECRUITING

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

    Beni-Suef University

    STUDY DIRECTOR

Central Study Contacts

Mohammed S ElSheemy, Ass. Prof.

CONTACT

01006117755mohammedshemy@yahoo.com

Ahmad Aref Al-Dessoukey, Ass. Prof.

CONTACT

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

January 4, 2019

First Posted

January 7, 2019

Study Start

January 11, 2019

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)