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Procedure

Miniaturized Percutaneous Nephrolithotomy for Kidney Stones

N/A
Recruiting
Led By Sriharan Sivalingam
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: ≥ 18 years old
Be older than 18 years old
Must not have
Prior ipsilateral upper urinary tract reconstructive procedures
Inability to give informed consent or unable to meet requirements of the study for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-7 days
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two methods for kidney stone treatment, both of which have proven safe and effective.

Who is the study for?
This trial is for adults over 18 with kidney stones sized between 10-25 mm, who can consent and meet study requirements. It's open to all ethnicities and genders. Those with a nephrostomy tube or ureteral stent already in place may join. People on blood thinners, with coagulation disorders, congenital kidney anomalies, previous kidney surgeries, or needing multiple access tracts are excluded.
What is being tested?
The study compares two surgical methods for removing kidney stones: one using a vacuum-assisted sheath and the other using a conventional sheath during mini-PCNL (a minimally invasive surgery). The goal is to determine which method is more effective for patients like you.
What are the potential side effects?
Potential side effects from both procedures include bleeding, infection risk at the site of surgery, pain where the stone was removed, possible damage to surrounding tissues or organs during the procedure, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery before on the same side of my upper urinary tract.
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I am able to understand and agree to the study's requirements.
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My surgery was changed to an open procedure.
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I am on blood thinners or have a history of bleeding disorders.
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I was born with kidney abnormalities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aim 1: Stone free rate
Aim 2: Intraoperative variables
Aim 3: Post-operative Outcomes and Complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: passive suction via conventional sheathActive Control2 Interventions
Group II: vacuum-assisted sheathActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,053 Previous Clinical Trials
1,371,084 Total Patients Enrolled
6 Trials studying Kidney Stones
3,726 Patients Enrolled for Kidney Stones
Sriharan SivalingamPrincipal InvestigatorPrincipal Investigator
~0 spots leftby Dec 2024
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