PNLNCT06797466
Three Dimensional Virtual Reconstruction (3D) in Percutaneous Nephrolithotomy
A study testing 3D imaging technique on the PCNL in people with PNL and Stone, Kidney, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PNL, Stone, Kidney
- What is being tested?
- 3D imaging technique on the PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with kidney stones larger than 2 cm and those with PCNL indication.
Who cannot join
- Patients with missing CT images, missing clinical information, or inaccessible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adıyaman University
Adıyaman
ADIYAMAN EDUCATION AND RESEARCH HOSPITAL, +90 416 216 10 15, adiyamaneah1@saglik.gov.tr
About this study
Official title: Investigation of the Effect of Three Dimensional Virtual Reconstruction (3D) on Percutaneous Nephrolithotomy Learning Curve in Specialist Training
The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.
- Conditions
- PNL, Stone, Kidney
- Being tested
- 3D imaging technique on the PCNL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D imaging technique on the PCNLProcedure or surgery
Establishing a percutaneous access route for the stone is the first and most important step in PCNL surgery. Choosing the perfect route, position and direction largely depends on surgical experience and the ability to understand renal/peri-renal anatomy. In general, a good CT scan of the abdomen and pelvis and an experienced surgeon are sufficient, but this requires significant time in the learning curve. The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.
| Study group | Role | What they receive |
|---|---|---|
| 3D imaging technique on the PCNL | Experimental | Not described Receives: Procedure: 3D imaging technique on the PCNL |
| standard PCNL | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with perioperative Bleeding.
Measured: immediately after the intervention/procedure/surgery
Number of Participants with stone free
Measured: 1 month after the intervention/procedure/surgery
leng of the hospital stay
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (1)
Number of Participants with Complication
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start21 Jan 2025
- Primary completion21 Jan 2025
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PNLStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedreddin Kalyenci, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797466
- Sponsor's protocol ID
- HRÜ/24.21.44
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Three Dimensional Virtual Reconstruction (3D) on Percutaneous Nephrolithotomy Learning Curve in Specialist Training
- ClinicalTrials.gov ID
- NCT06797466
- Acronym / sponsor ID
- HRÜ/24.21.44
- Conditions
- PNL, Stone, Kidney
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D imaging technique on the PCNL | Experimental | Procedure: 3D imaging technique on the PCNL |
| standard PCNL | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with kidney stones larger than 2 cm and those with PCNL indication.
Key exclusion criteria (1 listed)
- Patients with missing CT images, missing clinical information, or inaccessible
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 |
|---|---|---|
| 3D imaging technique on the PCNLEstablishing a percutaneous access route for the stone is the first and most important step in PCNL surgery. Choosing the perfect route, position and direction largely depends on surgical experience and the ability to understand renal/peri-renal anatomy. In general, a good CT scan of the abdomen and pelvis and an experienced surgeon are sufficient, but this requires significant time in the learning curve. The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training. | Procedure or surgery | 3D imaging technique on the PCNL |
Primary outcome
Number of Participants with perioperative Bleeding.
Time frame: immediately after the intervention/procedure/surgery
Number of Participants with stone free
Time frame: 1 month after the intervention/procedure/surgery
leng of the hospital stay
Time frame: immediately after the intervention/procedure/surgery
1 secondary outcome
Number of Participants with Complication
Time frame: immediately after the intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Related trials for PNL
Recruiting
Supine vs. Prone Mini-PCNL in Children
Kidney Calculi (or Renal Calculi / Nephrolithiasis), Supine Mini Percutaneous Nephrolithotomy
Not yet recruiting
Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)
MINS, Myocardial Injury After Noncardiac Surgery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D imaging technique on the PCNL in people with PNL and Stone, Kidney, run by Adiyaman University at 1 site in Turkey (Türkiye).
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 1 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: looking for participants now, as of the sponsor's last update on 9 May 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bedreddin Kalyenci, Doctor (+905554859583, bedreddin84@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with perioperative Bleeding. (time frame: immediately after the intervention/procedure/surgery). The study lists 3 primary outcomes in all. 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 9 May 2025.