Kidney StoneNCT07328659
Our Stone Fixation Technique to Improve Efficiency and Results of Peumatic Lithotripsy in Suction Mini-PCNL.
A study testing Peumatic lithotripsy in mini-pcnl in people with Kidney Stone and Calculi, Renal, run by Yasser Gamil Elnagar at 1 site in Egypt.
Trial summary
Prospective study to assist safty and efficieny of our technique of using peumatic lithotripsy with suction mini-pcnl. Read more about this study
- Who is it for?
- Ages 3 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone, Calculi, Renal
- What is being tested?
- Peumatic lithotripsy in mini-pcnl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- any patient with kidney stones less than 4 cm .
Who cannot join
- children less than 3 yrs.
- single kidney patient.
- patient with ectopic kidney and spinal deformities.
- unfit patient for surgry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Stone, Calculi, Renal
- Being tested
- Peumatic lithotripsy in mini-pcnl
- Keywords
- Urolithiasis, Endourology, Suction sheath
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peumatic lithotripsy in mini-pcnlProcedure or surgery
Using our technique to improve results of peumatic lithotripsy in suction mini-PCNL.
| Study group | Role | What they receive |
|---|---|---|
| Patient with kidney stones treated by our technique | Experimental | Prospective assesment of results. Receives: Procedure: Peumatic lithotripsy in mini-pcnl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone disintegration time
Assesment of peumatic lithotripsy time during the operation.
Measured: Day 1
Secondary outcomes (2)
Stone free rate
Presence of residual stones more than 3mm
Measured: -after the operation immediately and then after 1 month of the operation.
Rate of complications
rate of any intra or postoperative coplications.
Measured: Intraoperative and immediately post operative till one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 Jan 2024
- Primary completion15 Sep 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group quasi interventional prospective study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasser Gamil Elnagar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasser Gamil Elnagar, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328659
- Sponsor's protocol ID
- RAD-MC-2025-001
- Status last verified
- Jan 2025
- First submitted
- 6 Dec 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Stone Fixation Technique to Improve the Efficacy of Peumatic Lithotripsy With Suction Sheath in Mini-pcnl.
- ClinicalTrials.gov ID
- NCT07328659
- Acronym / sponsor ID
- RAD-MC-2025-001
- Conditions
- Kidney Stone, Calculi, Renal
- Keywords
- Urolithiasis, Endourology, Suction sheath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yasser Gamil ElnagarUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group quasi interventional prospective study.
| Arm | Type | Receives |
|---|---|---|
| Patient with kidney stones treated by our technique | Experimental | Procedure: Peumatic lithotripsy in mini-pcnlProspective assesment of results. |
Who may qualify
- Ages
- 3 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any patient with kidney stones less than 4 cm .
Key exclusion criteria (4 listed)
- children less than 3 yrs.
- single kidney patient.
- patient with ectopic kidney and spinal deformities.
- unfit patient for surgry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peumatic lithotripsy in mini-pcnlUsing our technique to improve results of peumatic lithotripsy in suction mini-PCNL. | Procedure or surgery | Patient with kidney stones treated by our technique |
Primary outcome
Stone disintegration time
Time frame: Day 1
Assesment of peumatic lithotripsy time during the operation.
2 secondary outcomes
Stone free rate
Time frame: -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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peumatic lithotripsy in mini-pcnl in people with Kidney Stone and Calculi, Renal, run by Yasser Gamil Elnagar at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone disintegration time (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.