Comparing two methods for kidney stone surgery
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
This study is testing two different ways to perform kidney stone surgery to see which method works better for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05993546 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure for treating kidney stones. Participants will undergo surgery using either a vacuum-assisted sheath or a standard sheath to access the kidney and remove stones. The study will involve approximately 90 patients at the Cleveland Clinic, with follow-up appointments scheduled 4-6 weeks post-surgery to assess outcomes. Both techniques are commonly used and have demonstrated safety and effectiveness for stones of similar size and location.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with kidney stones sized between 10-25 mm who are scheduled for prone mini-PCNL.
Not a fit: Patients with anticoagulation issues, congenital renal anomalies, or those who have had prior reconstructive procedures on the same kidney may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing kidney stone removal.
How similar studies have performed: While both techniques are established, this specific comparison of vacuum-assisted versus standard sheath in mini-PCNL is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Sriharan Sivalingam — Principal Investigator
- Study coordinator: Lauren Grimm
- Email: grimml@ccf.org
- Phone: 216-444-4650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.