- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328659
Our Stone Fixation Technique to Improve Efficiency and Results of Peumatic Lithotripsy in Suction Mini-PCNL.
April 13, 2026 updated by: Yasser Gamil Elnagar
Our Stone Fixation Technique to Improve the Efficacy of Peumatic Lithotripsy With Suction Sheath in Mini-pcnl.
Prospective study to assist safty and efficieny of our technique of using peumatic lithotripsy with suction mini-pcnl.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aswan Governorate
-
Aswān, Aswan Governorate, Egypt
- Radar medical centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient with kidney stones treated by our technique
Prospective assesment of results.
|
Using our technique to improve results of peumatic lithotripsy in suction mini-PCNL.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stone disintegration time
Time Frame: Day 1
|
Assesment of peumatic lithotripsy time during the operation.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stone free rate
Time Frame: -after the operation immediately and then after 1 month of the operation.
|
Presence of residual stones more than 3mm
|
-after the operation immediately and then after 1 month of the operation.
|
|
Rate of complications
Time Frame: Intraoperative and immediately post operative till one week.
|
rate of any intra or postoperative coplications.
|
Intraoperative and immediately post operative till one week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2024
Primary Completion (Actual)
September 15, 2025
Study Completion (Actual)
April 1, 2026
Study Registration Dates
First Submitted
December 6, 2025
First Submitted That Met QC Criteria
January 8, 2026
First Posted (Actual)
January 9, 2026
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 13, 2026
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Urolithiasis
Other Study ID Numbers
- RAD-MC-2025-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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