A study in adults with kidney stones to compare three stone removal methods Pneumatic, Laser, and Shock Pulse Lithotripsy and see which is safest and most effective

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pneumatic Lithotripsy, Holmium Laser, and Shock Pulse Lithotripsy in Percutaneous Nephrolithotomy (PCNL) for Renal Stones in Patients With Nephrolithiasis - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085105

Enrollment

144

Registered

2025-04-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N200- Calculus of kidney

Interventions

Intervention1: Pneumatic lithotripsy: Mechanical lithotripsy using a pneumatic device-Nidhi Meditech EWS SWISS Lithoclast to fragment renal calculi in 1 day intervention during PCNL surgery

participant followed for 4 weeks postoperatively. Control Intervention1: Holmium Laser Lithotripsy: Laser energy applied via Quanta medical system using a flexible fiber to disintegrate renal calculi

participant followed for 4 weeks postoperatively. Control Intervention2: Shock pulse Lithotripsy: Dual-action lithotripsy using ultrasonic and ballistic energy to fragment renal calculi via Olympus me

participant followed for 4 weeks postoperatively. Control Intervention3: Percutaneous nephrolithotomy: Pneumatic lithotripsy- The device used will be: Nidhi Meditech EWS SWISS Lithoclast for 2 years d

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with Guy s stone score 3 or 4. 2.Patients with evidence of functioning kidney on the respective side.

Exclusion criteria

Exclusion criteria: 1.Patients who do not give consent. 2.Patients with associated urinary tract infection that is inadequately treated. 3.Patients with uncorrected coagulopathy. 4.Patients with residual renal calculus following the previous intervention. Patients with chronic kidney disease stage 4 or 5. Pregnant females.

Design outcomes

Primary

Measure	Time frame
Proportion of patients who are stone-free post-operatively, assessed by imagingTimepoint: 2 days postoperatively	—

Secondary

Measure	Time frame
Time taken from the initiation of lithotripsy to complete fragmentation of the stone(s) during PCNL, measured intraoperatively. Timepoint: Measured from the start of energy delivery (lithotripsy activation) to the completion of visible stone fragmentation during the surgical procedure (intraoperative).;Drop in hemoglobin levelsTimepoint: Post operative day 1	—

Countries

India

Contacts

Public ContactDr Deepak Prakash Bhirud

AIIMS Jodhpur

deepakprakashbhirud05@gmail.com7835056077

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026