Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Description

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Conditions

Kidney Stone

Study Overview

Study Details

Study overview

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Condition
Kidney Stone
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients with planned prone mini-PCNL and a preoperative NCCT
  • * Primary stone size: 10-25 mm
  • * Pre-existing indwelling nephrostomy tube or ureteral stent permitted
  • * Age: ≥ 18 years old
  • * Gender: all
  • * Ethnicity: all
  • * Capable of giving informed consent
  • * Capable and willing to fulfill requirements of the study
  • * Anticoagulated or history of coagulopathy
  • * Congenital renal anomalies
  • * Prior ipsilateral upper urinary tract reconstructive procedures
  • * Conversion to open procedure
  • * Multiple access tracts
  • * Inability to give informed consent or unable to meet requirements of the study for any reason

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Sriharan Sivalingam, PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

2024-12