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Not yet recruitingNCT07393178miniPCNLUpdated Feb 6, 2026

Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones

An interventional study of mini percutaneous nephrolithotomy in Renal Stones and Renal Calculi > 2 cm, sponsored by Mansoura University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigator will compare between holmium laser setting during miniPCNL for renal stones as regard safety \& efficacy

Read the detailed description

The first 80 consecutive Patients presented to the department of urology, Mansoura Urology and Nephrology Center and fulfilling the inclusion criteria will be included in the present study.

Preoperatively, all patients will be thoroughly evaluated by medical history and physical examination including body mass index (BMI), laboratory assessment (including urine analysis/culture, serum biochemistry, CBC, bleeding profile).

Radiological assessment will include plain X-ray Kidney-Ureter-Bladder (KUB), abdominal ultrasound and non-contrast computed tomography (NCCT).

NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, location, largest diameter, burden and density will be assessed.

Culture based antibiotic is given. Under spinal anaesthesia, the patient is initially placed in lithotomy position for retrograde ureteral catheter placement, then repositioned to prone or modified supine position for percutaneous access.

Under fluoroscopic guidance, an 18G Chiba needle is used to access a posterior calyx or the appropriate target calyx). Contrast confirms the collecting system entry.

Dilation is performed, typically up to 14-20 Fr. A mini-nephroscope (15 Fr) is inserted through an appropriate sheath. Irrigation is maintained using gravity or low-pressure systems.

Holmium: YAG laser is used for lithotripsy. high pulse power will be capped at 40 W, while low pulse power settings will remain between 10-20 W. Fragments are evacuated via vacuum cleaner effect or basket through the sheath.

Depending on intraoperative findings, a nephrostomy tube and/or double-J stent may be placed. Tubeless approach may be considered.

02

Conditions studied

  • Renal Stones
  • Renal Calculi > 2 cm

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Keywords

  • mini-PCNL
  • holmium-YAG
  • laser lithotripsy
03

In context

Nephrolithiasis

324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.

This study's planned enrollment of 70 is below the median of 92 across 257 interventional studies indexed under Nephrolithiasis.

Browse Nephrolithiasis studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Renal Stones \< 20 mm indicated for intervention (pain, infection, obstructing stone causing hydronephrosis or parenchymal affection)
  • obtained

Exclusion criteria

Exclusion Criteria:

  • Active urinary tract infection
  • Bleeding diathesis
  • Pregnancy
  • Anatomical anomalies impeding access e.g. ectopic malrotated kidneys, crossed fused kidneys...etc.)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    high power arm

    will undergo miniPCNL will high power laser setting

    Procedure: mini percutaneous nephrolithotomy

  • Placebo comparator
    low power group

    will undergo miniPCNL will low power laser setting

    Procedure: mini percutaneous nephrolithotomy

Interventions

  • Proceduremini percutaneous nephrolithotomy

    Under fluoroscopic guidance, an 18G Chiba needle is used to access a posterior calyx or the appropriate target calyx). Contrast confirms the collecting system entry. Dilation is performed, typically up to 14-20 Fr. A mini-nephroscope (15 Fr) is inserted through an appropriate sheath. Irrigation is maintained using gravity or low-pressure systems. Holmium: YAG laser is used for lithotripsy. high pulse power will be capped at 40 W, while low pulse power settings will remain between 10-20 W. Fragments are evacuated via vacuum cleaner effect or basket through the sheath.

    Also known as: miniperc, miniPCNL

06

What researchers measure

Primary outcomes

  1. operative time

    time from introduction of nephroscope till nephrostomy tube fixation

    Time frame: during mini-PCNL procedure (intraoperative )

Secondary outcomes

  1. post operative complication

    number of patients that will develop post operative fever, hematuria, or will require blood transfusion

    Time frame: 2 days

  2. stone free rate at 3 month

    presence of residual stones requiring reintervention

    Time frame: 3 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Nov 2026, 7 months later.

Of 134 non-industry interventional studies with no phase under Nephrolithiasis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 7 months is below that.

Counting every sponsor, half of 140 studies reached it within 24 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2025
First posted
Feb 6, 2026
StartEst.
Mar 15, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Jan 30, 2027
Last update
Feb 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07393178
Responsible party
Ahmed Elghamry (Resident in urology, Mansoura University) — Principal investigator
First posted
Feb 6, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Feb 6, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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