Our Stone Fixation Technique to Improve Efficiency and Re... | NCT07328659

Studies
Our Stone Fixation Technique to Improve Efficiency and Results of Peumatic Lithotripsy in Suction Mini-PCNL.

NCT07328659

Sponsor

Yasser Gamil Elnagar

Status

Completed

Last Update Posted

Apr 15, 2026Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Kidney Stone
Calculi, Renal

Interventions

Peumatic lithotripsy in mini-pcnl

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 2025

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

Jan 15, 2024Actual

Primary Completion Date

Sep 15, 2025Actual

Completion Date

Apr 1, 2026Actual

First Submitted Date

Dec 6, 2025

First Submission Date that Met QC Criteria

Jan 8, 2026

First Posted Date

Jan 9, 2026Actual

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

Apr 13, 2026

Last Update Posted Date

Apr 15, 2026Actual

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

Prospective study to assist safty and efficieny of our technique of using peumatic lithotripsy with suction mini-pcnl.

Detailed Description

anew techniqe was designed to improve the results of pneumatic lithotripsy in suction mini-PCNL by:

Customize our instrument to be suitable for a short 12 Fr nephroscope.
using certain measures to avoid stone migration during pneumatic disintegration.

By fixing stones during disintegration and suction.

Our puncture strategy was planned to prevent stone migration.
Use a suction sheath to gently fix the stone between the tip of the sheath and the inner wall of the kidney and disintegrate it from inside the sheath.
The dormai basket was used to fix the stone in front of the sheath in difficult situations.

The investigators will assess disintegration time as the primary endpoint and stone-free rate and complications as secondary endpoints.

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with kidney stones treated by our technique	Experimental	Prospective assesment of results.	Procedure: Peumatic lithotripsy in mini-pcnl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peumatic lithotripsy in mini-pcnl	Procedure	Using our technique to improve results of peumatic lithotripsy in suction mini-PCNL.	Patient with kidney stones treated by our technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone disintegration time	Assesment of peumatic lithotripsy time during the operation.	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Stone free rate	Presence of residual stones more than 3mm	-after the operation immediately and then after 1 month of the operation.
Rate of complications	rate of any intra or postoperative coplications.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any patient with kidney stones less than 4 cm .

Exclusion Criteria:

children less than 3 yrs.
single kidney patient.
patient with ectopic kidney and spinal deformities.
unfit patient for surgry.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radar medical centre		Aswān	Aswan Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D052878	Urolithiasis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided