Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedStudy Start
First participant enrolled
August 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJanuary 7, 2026
January 1, 2026
2.5 years
August 7, 2023
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Aim 1: Stone free rate
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
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
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
Study Arms (2)
vacuum-assisted sheath
ACTIVE COMPARATORpassive suction via conventional sheath
ACTIVE COMPARATORInterventions
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
conventional access sheath for stone retrieval using current technique via passive suction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
Ho L, Chehroudi C, Sivalingam S. Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths for Treatment of Nephrolithiasis. J Urol. 2024 Sep;212(3):504-506. doi: 10.1097/JU.0000000000004057. Epub 2024 May 31. No abstract available.
PMID: 38820486DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sriharan Sivalingam
Principal Investigator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2023
First Posted
August 15, 2023
Study Start
August 29, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
January 7, 2026
Record last verified: 2026-01