Flexible Ureteroscopy Versus ESWL in the Management of Lo... | NCT02658942

Studies
Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

NCT02658942

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 20, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Renal Stones

Interventions

Ureteroscopy
Shockwave lithotripsy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

May 2012Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 14, 2016

First Submission Date that Met QC Criteria

Jan 19, 2016

First Posted Date

Jan 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2016

Last Update Posted Date

Jan 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:YAG laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ureteroscopy	Procedure	In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.	Ureteroscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone free rate	no stone fragments or having fragments <3mm	3 months

Secondary Outcomes

Measure	Description	Time Frame
Complications	Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Bleeding tendency
distal obstruction
Anomalies of the urinary tract
Solitary kidney

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammed S ElSheemy, M.D	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University Hospitals		Cairo		12222	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D053040	Nephrolithiasis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018666	Ureteroscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided