Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
NCT ID: NCT05993546
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-08-29
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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vacuum-assisted sheath
vacuum assisted sheath
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
passive suction via conventional sheath
passive suction via conventional sheath
conventional access sheath for stone retrieval using current technique via passive suction
Interventions
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vacuum assisted sheath
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
passive suction via conventional sheath
conventional access sheath for stone retrieval using current technique via passive suction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Sriharan Sivalingam
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-104
Identifier Type: -
Identifier Source: org_study_id
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