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Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

Primary Purpose

Ureteral Calculi

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

ureteroscopy with safety guide-wire

ureteroscopy alone

without safety guide-wire

with safety guide-wire

About this trial

This is an interventional treatment trial for Ureteral Calculi focused on measuring Ureteral Calculi, safety guide-wire, ureteroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

ureteral stone who underwent ureteroscopy

Exclusion Criteria:

transplant kidney
coagulopathy disorders
history of ureteral stenosis
skeletal disorders

Sites / Locations

Shahid beheshty university of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

ureteroscopy with safety guide-wire

ureteroscopy alone

with safety guide-wire

without safety guide-wire

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

stone free rate

rate of patients without any residue of stone

Secondary Outcome Measures

operation time

the time between insertion of ureteroscopy till insertion of catheter

grade of kidney hydronephrosis

grade of hydronephrosis is classified as: 0-4 grades

ureteral injury

ureteral injury is classified as: Mucosal abrasion, Ureteral perforation, Intussusception / avulsion

Full Information

NCT ID

NCT03726502

First Posted

April 19, 2017

Last Updated

December 14, 2018

Sponsor

Isfahan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03726502

Brief Title

Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

Official Title

Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

April 1, 2017 (Actual)

Study Completion Date

April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Isfahan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ureteral Calculi

Keywords

Ureteral Calculi, safety guide-wire, ureteroscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ureteroscopy with safety guide-wire

Arm Type

Active Comparator

Arm Description

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

Arm Title

ureteroscopy alone

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

with safety guide-wire

Arm Type

Active Comparator

Arm Description

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

Arm Title

without safety guide-wire

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

ureteroscopy with safety guide-wire

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

ureteroscopy alone

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

without safety guide-wire

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

with safety guide-wire

Intervention Description

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

Primary Outcome Measure Information:

Title

stone free rate

Description

rate of patients without any residue of stone

Time Frame

3 months after surgery

Secondary Outcome Measure Information:

Title

operation time

Description

the time between insertion of ureteroscopy till insertion of catheter

Time Frame

at time of surgery

Title

grade of kidney hydronephrosis

Description

grade of hydronephrosis is classified as: 0-4 grades

Time Frame

3 months after surgery

Title

ureteral injury

Description

ureteral injury is classified as: Mucosal abrasion, Ureteral perforation, Intussusception / avulsion

Time Frame

at time of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ureteral stone who underwent ureteroscopy Exclusion Criteria: transplant kidney coagulopathy disorders history of ureteral stenosis skeletal disorders

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abbas Basiri, prof

Organizational Affiliation

Shahid beheshty university of medical sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Shahid beheshty university of medical sciences

City

Tehrān

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

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