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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
Male and female patients
Age ≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am either male or female.
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I am 18 years old or older.
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I am able to understand and agree to participate in the study.
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I am scheduled for a kidney stone removal surgery at a participating hospital.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin
Secondary outcome measures
Complication Rates
IL-6 Inflammatory Markers
Procalcitonin- Inflammatory Markers
+2 more

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
1,021 Previous Clinical Trials
1,365,640 Total Patients Enrolled
5 Trials studying Kidney Stones
3,640 Patients Enrolled for Kidney Stones
Columbia UniversityOTHER
1,426 Previous Clinical Trials
2,473,718 Total Patients Enrolled
2 Trials studying Kidney Stones
230 Patients Enrolled for Kidney Stones
Massachusetts General HospitalOTHER
2,924 Previous Clinical Trials
13,193,333 Total Patients Enrolled
2 Trials studying Kidney Stones
3,080 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for participation in this experiment?

"The clinicaltrials.gov page for this trial unveils that it is not actively searching for participants as the most recent update was posted on May 19th 2021 and no further recruitment has been conducted since its initial posting on May 1st 2022. Nevertheless, there are 599 other medical studies currently enrolling candidates across the globe."

Answered by AI
~4 spots leftby Apr 2024