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Ureteral Access Sheath

ClearPetra for Kidney Stones (VA-UAS vs trad Trial)

N/A
Waitlist Available
Led By Wilson Molina, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
Be older than 18 years old
Must not have
Uncorrected coagulopathy
Patients with urinary diversions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Summary

"This trial aims to compare a new vacuum-assisted ureteral access sheath called ClearPetra with traditional approaches in treating kidney stones smaller than 2 cm. The new device allows for continuous stone

Who is the study for?
This trial is for individuals with kidney stones smaller than 2 cm who are undergoing ureteroscopy. The study aims to include those who can benefit from a new device designed to improve the procedure and potentially reduce postoperative infections.
What is being tested?
The ClearPetra vacuum-assisted ureteral access sheath is being tested against traditional methods (no sheath or non-vacuum-assisted sheaths) in American patients, focusing on its efficiency in stone removal and infection rate reduction after surgery.
What are the potential side effects?
Potential side effects may include discomfort during the procedure, possible injury to the ureter mucosa, bleeding, urinary tract infections, or other complications related to ureteroscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific kidney stone removal surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder that hasn't been treated.
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I have a urinary diversion.
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I am currently pregnant.
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I am having surgery to remove kidney stones from both sides at once.
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I have had surgeries that were not by choice.
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I have a known abnormality in my urinary system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 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
To compare Stone Free Status between ClearPetra and traditional approach
Secondary study objectives
To compare Total operative time between ClearPetra and traditional approach
To compare Urinary tract infection between ClearPetra and traditional approach

Trial Design

2Treatment groups
Active Control
Group I: 1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATHActive Control1 Intervention
In Arm 1, participants will undergo RIRS with ClearPetra™ vacuum-assisted ureteral access sheath. Participants will undergo RIRS per standard of care.
Group II: 2. RIRS WITH TRADITIONAL APPROACHActive Control1 Intervention
In Arm 2, participants will undergo RIRS a traditional approach (no sheath or non-vacuum-assisted sheath). The treating investigator will decide whether to use a regular UAS based on their preference and/or availability. * No ureteral access sheath * Navigator™ Ureteral Access Sheath 11/13 Fr (Boston Scientific®) * Navigator™ Ureteral Access Sheath 12/14 Fr (Boston Scientific®)

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,305 Total Patients Enrolled
3 Trials studying Kidney Stones
180 Patients Enrolled for Kidney Stones
Wilson Molina, MDPrincipal InvestigatorStudy Principal Investigator
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Kidney Stones
100 Patients Enrolled for Kidney Stones
~100 spots leftby May 2025
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