ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach (VA-UAS vs trad)

May 1, 2026 updated by: Wilson Molina, University of Kansas Medical Center

ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach in Retrograde Intrarenal Surgery. A Randomized Controlled Trial

Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure.

Recently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration.

Because there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Retrograde intrarenal surgery (RIRS) is now considered gold-standard for treatment of renal stones smaller than 2 cm. This procedure often employs a ureteral access sheath (UAS), as it helps to reduce intrarenal pressure and protects the ureter mucosa when basketing is required. However, the challenge imposed by residual stone fragments and sepsis remains. Additionally, natural elimination of residual stone fragments may induce renal colic, hematuria an even the potential for new stone development. Recently, a new vacuum-assisted ureteral access sheath (VA-UAS) named ClearPetra™ provides concomitant stone fragmentation and aspiration.

The new ClearPetra™ vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones. It is a disposable access sheath equipped with a continuous flow aspiration mechanism. Previous studies have demonstrated the safety and effectiveness of ClearPetra™ in RIRS Comprehensive comparative investigations between ClearPetra™ and traditional UAS in RIRS are lacking in American population. We aim to compare the outcomes of using VA-UAS (ClearPetra™) or traditional approach (no sheath or non-vacuum-assisted sheath) to treat patients with stone burden between 1.0 - 2.5 cm.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Males or females over18 years of age
  2. Undergoing primary flexible ureteroscopy for retrograde intrarenal surgery
  3. Total stone burden between 1.0 to 2.5 cm

Exclusion Criteria:

  1. Undergoing bilateral stone treatment during the same procedure
  2. Patients with known genitourinary anatomical abnormalities
  3. Uncorrected coagulopathy
  4. Patients with urinary diversions
  5. Chronic external urinary catheters
  6. Women who are pregnant
  7. Immunosuppressed patients
  8. Non-elective procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH

In Arm 1, participants will undergo RIRS with ClearPetra™ vacuum-assisted ureteral access sheath.

Participants will undergo RIRS per standard of care.
Device: ClearPetra Ureteral access sheath
Patients will be randomly assigned (1:1) to vacuum-assisted (ClearPetra) or traditional approach group for retrograde intrarenal surgery according to standard of care.
No Intervention: 2. RIRS WITH TRADITIONAL APPROACH

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®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone Free Status between ClearPetra and traditional approach
Time Frame: 90 days
Stone free is defined as no residual stones >2mm in post operative CT scan
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total operative time between ClearPetra and traditional approach
Time Frame: 1 day
Time from scope insertion to scope removal from the patient
1 day
Urinary tract infection between ClearPetra and traditional approach
Time Frame: 30 days of procedure
Data collection searching for urine tract infection signs, symptoms, antibiotic administration and culture
30 days of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Wilson Molina, MD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2025

Primary Completion (Actual)

January 21, 2026

Study Completion (Actual)

February 27, 2026

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00161273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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