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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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

Stone Free Status between ClearPetra and traditional approach

Secondary study objectives

Total operative time between ClearPetra and traditional approach

Urinary tract infection between ClearPetra and traditional approach

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: 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®)

0 / 7Eligibility criteria met