Treatment of Upper Ureteric Stones | NCT02469766

Studies
Treatment of Upper Ureteric Stones

NCT02469766

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Aug 30, 2016Estimated

Enrollment

240Estimated

Phase

Phase 4

Conditions

Ureteric Stones

Interventions

SWL
Semirigid URS
Flexible URS

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Aug 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jun 9, 2015

First Submission Date that Met QC Criteria

Jun 10, 2015

First Posted Date

Jun 11, 2015Estimated

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

Aug 28, 2016

Last Update Posted Date

Aug 30, 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

This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

Detailed Description

This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extracorporeal Shockwaves	Active Comparator	Patients in this arm will undergo SWL	Procedure: SWL
Semirigid URS	Active Comparator	Patients in this arm will undergo Semirigid Ureteroscopy	Procedure: Semirigid URS
Flexible URS	Active Comparator	Patients in this arm will undergo Flexible Ureteroscopy	Procedure: Flexible URS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SWL	Procedure	Patients in this arm will undergo SWL	Extracorporeal Shockwaves

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone free rate	The stone free rate will be evaluated with non-contrast CT	3 months

Secondary Outcomes

Measure	Description	Time Frame
Complication rate	Complications will be classified according to modified Clavien Dindo	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radio-opaque stones
less than or equal 1 cm

Exclusion Criteria:

Active UTI
Coagulopathy
Pregnancy
Ureteric stricture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Muhamad M abdallateef, MD	Contact	01009681644		seif_1901@yahoo.com
Ahmed R EL-Nahas, MD	Contact	+20502202222	1699	ar_el_nahas@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmed M Shoma, MD	Mansoura University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology and Nephrology Center	Recruiting	Al Mansurah	Dakhlia	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided