NCT03726502

Brief Summary

The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

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
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
Last Updated

December 19, 2018

Status Verified

October 1, 2018

Enrollment Period

Same day

First QC Date

April 19, 2017

Last Update Submit

December 14, 2018

Conditions

Ureteral Calculi

Keywords

Ureteral Calculisafety guide-wireureteroscopy

Outcome Measures

Primary Outcomes (1)

  • stone free rate

    rate of patients without any residue of stone

    3 months after surgery

Secondary Outcomes (3)

  • operation time

    at time of surgery

  • grade of kidney hydronephrosis

    3 months after surgery

  • ureteral injury

    at time of surgery

Study Arms (4)

ureteroscopy with safety guide-wire

ACTIVE COMPARATOR

ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy

Procedure: ureteroscopy with safety guide-wireProcedure: with safety guide-wire

ureteroscopy alone

PLACEBO COMPARATOR

ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy

Procedure: ureteroscopy aloneProcedure: without safety guide-wire

with safety guide-wire

ACTIVE COMPARATOR

ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy

Procedure: ureteroscopy with safety guide-wireProcedure: with safety guide-wire

without safety guide-wire

PLACEBO COMPARATOR

ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy

Procedure: ureteroscopy aloneProcedure: without safety guide-wire

Interventions

ureteroscopy with safety guide-wirePROCEDURE

ureteroscopy with use of safety guide-wire in treatment of ureteral stone

ureteroscopy with safety guide-wirewith safety guide-wire
ureteroscopy alonePROCEDURE

ureteroscopy without use of safety guide-wire in treatment of ureteral stone

ureteroscopy alonewithout safety guide-wire
without safety guide-wirePROCEDURE

ureteroscopy without use of safety guide-wire in treatment of ureteral stone

ureteroscopy alonewithout safety guide-wire
with safety guide-wirePROCEDURE

ureteroscopy with use of safety guide-wire in treatment of ureteral stone

ureteroscopy with safety guide-wirewith safety guide-wire

Eligibility Criteria

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

You may qualify if:

  • ureteral stone who underwent ureteroscopy

You may not qualify if:

  • transplant kidney
  • coagulopathy disorders
  • history of ureteral stenosis
  • skeletal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid beheshty university of medical sciences

Tehrān, Iran

Location

MeSH Terms

Conditions

Ureteral Calculi

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Abbas Basiri, prof

    Shahid beheshty university of medical sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 19, 2017

First Posted

October 31, 2018

Study Start

April 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

December 19, 2018

Record last verified: 2018-10

Locations

IR(1)