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

January 5, 2026 updated by: The Cleveland Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. 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.

Two procedure types will be investigated:

  1. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone.
  2. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone.

Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vacuum-assisted sheath
Device: vacuum assisted sheath
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
Active Comparator: passive suction via conventional sheath
Device: passive suction via conventional sheath
conventional access sheath for stone retrieval using current technique via passive suction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1: Stone free rate
Time Frame: 6 weeks
The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray
6 weeks
Aim 2: Intraoperative variables
Time Frame: 3-7 days
Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL
3-7 days
Aim 3: Post-operative Outcomes and Complications
Time Frame: 1 day
Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Sriharan Sivalingam, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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