NCT03388060

Brief Summary

compare the efficacy of of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm renal stones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

December 23, 2017

Last Update Submit

August 2, 2018

Conditions

Urologic DiseasesStone, UrinaryStone, KidneyESWLRadiolucent Calculus of Urinary TractDissolution

Keywords

Oral Dissolution TherapyKidney stoneESWL

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    Free renal units from stones

    3 months

Study Arms (3)

Ultrasound guided SWL

ACTIVE COMPARATOR

ultrasound guided SWL for Radiolucent stone

Procedure: Ultrasound guided SWL

Dissolution therapy

ACTIVE COMPARATOR

Dissolution therapy for Radiolucent stone

Procedure: Dissolution therapy

Combined ultrasound guided SWL and dissolution therapy

ACTIVE COMPARATOR

Combined treatment for Radiolucent stone.

Procedure: Combined ultrasound guided SWL and dissolution therapy

Interventions

Ultrasound guided SWLPROCEDURE

Ultrasound guided SWL for radiolucent renal stone

Ultrasound guided SWL
Dissolution therapyPROCEDURE

Alkalinization dissolution therapy for radiolucent renal stone

Dissolution therapy
Combined ultrasound guided SWL and dissolution therapyPROCEDURE

Combined ultrasound guided SWL and alkalinization dissolution therapy for radiolucent renal stone

Combined ultrasound guided SWL and dissolution therapy

Eligibility Criteria

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

You may qualify if:

  • Adult patient with 1-2.5 cm renal stones.
  • Normal Serum creatinine
  • Radiolucent stone by X-ray

You may not qualify if:

  • Pregnancy.
  • Bleeding diatheses.
  • Patients with a pacemaker.
  • Uncontrolled UTIs.
  • Severe skeletal malformations.
  • Severe obesity which prevent targeting of the stone; BMI (40 or more).
  • Arterial aneurysm in the vicinity of the stone.
  • Anatomical obstruction distal to the stone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urologic DiseasesUrinary CalculiKidney Calculi

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNephrolithiasisKidney Diseases

Study Officials

  • Khalid Sheir, MD

    Shock wave unit chief - Urology and nephrology center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 2, 2018

Study Start

April 1, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

August 6, 2018

Record last verified: 2018-08

Locations

EG(1)