NCT02658942

Brief Summary

to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 14, 2016

Last Update Submit

January 19, 2016

Conditions

Renal Stones

Keywords

renal stoneslower calyxUreteroscopyShockwave lithotripsyHolmium laserAdultKidney

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    no stone fragments or having fragments \<3mm

    3 months

Secondary Outcomes (1)

  • Complications

    3 years

Study Arms (2)

Ureteroscopy

ACTIVE COMPARATOR

Intervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy

Procedure: Ureteroscopy

Shockwave lithotripsy

ACTIVE COMPARATOR

Intervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor

Procedure: Shockwave lithotripsy

Interventions

UreteroscopyPROCEDURE

In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.

Also known as: Flexible Ureteroscopy
Ureteroscopy
Shockwave lithotripsyPROCEDURE

In Group B patients, a Siemens Lithostar Lithotriptor

Also known as: ESWL
Shockwave lithotripsy

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral
  • radiopaque stone(s)
  • \< 2 cm
  • located in the lower calyx.

You may not qualify if:

  • Bleeding tendency
  • distal obstruction
  • Anomalies of the urinary tract
  • Solitary kidney

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, 12222, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Mohammed S ElSheemy, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

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
Assistant professor

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 20, 2016

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

EG(1)