← Back to Search

Procedure

Standard vs Mini-PCNL for Kidney Stones

N/A
Recruiting
Led By Manoj Monga, MD
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
Patients planned for PCNL at participating institutions
Must not have
Conversion to open procedure
Anticoagulated or history of coagulopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the outcomes of two different types of kidney stone surgery.

Who is the study for?
This trial is for adults over 18 who can consent to participate, are scheduled for PCNL (a procedure to remove kidney stones) at certain hospitals, and have a stone size of 10-20mm. It's open to all genders and ethnicities. Those with multiple access tracts, preoperative stents or tubes, coagulation issues, or unable to give consent are excluded.
What is being tested?
The study compares standard PCNL versus mini-PCNL in terms of patient outcomes. Participants will be randomly assigned to receive either the standard or the smaller-scale version of this kidney stone removal procedure.
What are the potential side effects?
Potential side effects from both types of PCNL may include bleeding, infection risk increase due to surgery, pain at the site of operation, possible damage to surrounding tissues/organs during the procedure and post-operative complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am scheduled for a kidney stone removal surgery at a participating hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My surgery was changed to an open procedure.
Select...
I am on blood thinners or have a history of bleeding disorders.
Select...
I am willing and able to give informed consent to participate in the study.
Select...
I have a tube placed in my kidney or ureter before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 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
Hemoglobin
Secondary study objectives
Complication Rates
IL-6 Inflammatory Markers
Procalcitonin- Inflammatory Markers
+2 more

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: Mini-PCNLActive Control1 Intervention
Patients receive a mini-PCNL procedure using a 16 fr tract
Group II: Standard PCNLActive Control1 Intervention
Patients receive a standard PCNL procedure using a 24 fr tract

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
Vanderbilt University Medical CenterOTHER
902 Previous Clinical Trials
938,411 Total Patients Enrolled
5 Trials studying Kidney Stones
430 Patients Enrolled for Kidney Stones
Duke UniversityOTHER
2,455 Previous Clinical Trials
2,971,462 Total Patients Enrolled
2 Trials studying Kidney Stones
260 Patients Enrolled for Kidney Stones

Media Library

PCNL (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04069013 — N/A
Kidney Stones Research Study Groups: Mini-PCNL, Standard PCNL
Kidney Stones Clinical Trial 2023: PCNL Highlights & Side Effects. Trial Name: NCT04069013 — N/A
PCNL (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069013 — N/A
~3 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top