Can Shear Wave Elastography Predict the Success of ESWL:... | NCT05995652

Studies
Can Shear Wave Elastography Predict the Success of ESWL: a Prospective Study

NCT05995652

Sponsor

Abdelrahim Elsherbiny

Status

Completed

Last Update Posted

Feb 5, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Kidney Stone

Interventions

elastography

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

Feb 2024

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

Aug 30, 2023Actual

Primary Completion Date

Jan 21, 2024Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

Aug 9, 2023

First Submission Date that Met QC Criteria

Aug 15, 2023

First Posted Date

Aug 16, 2023Actual

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

Feb 2, 2024

Last Update Posted Date

Feb 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelrahim Elsherbiny, assistant lecturer at urology department, Ain shams university, Ain Shams UniversitySponsor-Investigator

Lead Sponsor

Abdelrahim ElsherbinyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal stones treatment ? A prospective study

Detailed Description

Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is recommended as the first choice in the treatment of small and medium sized renal stones and proximal ureteral stones.

This study is a trial to determine the predictive role of shear wave elastography in the success of ESWL management of kidney stones.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESWL sucess and failed gps		post ESWL 50 pt large gp will be devided into sucess gp and failed gp	Procedure: elastography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
elastography	Procedure	elastography	ESWL sucess and failed gps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stone free rate	post ESWL	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients more than 18 years
With single radiopaque renal stone
Ranging in size from (1-1,5 cm) for ESWL.

Exclusion Criteria:

Any urological abnormal anatomy
Lower calyceal stone more than 1cm
Impaired renal functions
Uncorrected coagulopathy.
Active UTI Pregnancy Single kidney Multiple stones

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

1 gp of 50 pts will be subjected to ESWL and will be divided into 2 other gps success and failed

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
tarek elzayat, prof.dr.	AinShams	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Ain Shams University		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided