NCT05993546 Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
| NCT ID | NCT05993546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-08-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-08-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sriharan Sivalingam
PRINCIPAL INVESTIGATOR
Principal Investigator
Frequently Asked Questions
Who can join the NCT05993546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05993546 currently recruiting?
Yes, NCT05993546 is actively recruiting participants. Contact the research team at grimml@ccf.org for enrollment information.
Where is the NCT05993546 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05993546 clinical trial?
NCT05993546 is sponsored by The Cleveland Clinic. The principal investigator is Sriharan Sivalingam at Principal Investigator. The trial plans to enroll 90 participants.
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