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Standard vs Mini-PCNL for the Treatment of Stone Disease

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Enrolling

Conditions

Kidney Diseases
Kidney Stone
Urolithiasis
Ureteral Calculi
Kidney Calculi

Treatments

Procedure: PCNL

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.

Full description

This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients planned for PCNL at participating institutions
  • Age ≥ 18 years old
  • Male and female patients
  • Patients of all ethnic backgrounds
  • Stone size 10-20mm

Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.

Exclusion criteria

  • Conversion to open procedure
  • Multiple access tracts
  • Anticoagulated or history of coagulopathy
  • Preoperative ureteral stent or nephrostomy tube placement
  • Technical problems/impossibility of localizing the stone on the day of intervention

Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Standard PCNL
Active Comparator group
Description:
Patients receive a standard PCNL procedure using a 24 fr tract
Treatment:
Procedure: PCNL
Mini-PCNL
Active Comparator group
Description:
Patients receive a mini-PCNL procedure using a 16 fr tract
Treatment:
Procedure: PCNL

Trial contacts and locations

1

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Central trial contact

Naveen Kachroo, MD; Manoj Monga, MD

Data sourced from clinicaltrials.gov

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