ClearPetra for Kidney Stones

(VA-UAS vs trad Trial)

Overseen By Jane Ledesma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Bilateral stone treatment, Anatomical abnormalities, Coagulopathy, Urinary diversions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the ClearPetra Vacuum-assisted Ureteral Access Sheath treatment for kidney stones?

Research shows that the ClearPetra sheath allows for continuous stone removal and a clear view during procedures, and has been successfully used in a case of ureteroscopic lithotripsy for a large ureteral stone. Additionally, similar vacuum-assisted techniques have been effective in managing kidney stones by improving stone clearance and controlling pressure during surgery. ^{1 2 3 4 5}

Is the ClearPetra Vacuum-assisted Ureteral Access Sheath safe for use in humans?

The ClearPetra device has been used in procedures for kidney stones, and its safety has been reported in some studies, although there are still questions about the safety of ureteral access sheaths in general. Some research has looked at potential injuries to the ureter (the tube connecting the kidney to the bladder) from using these sheaths, but specific safety data for ClearPetra is limited. ^{1 2 6 7 8}

How is the ClearPetra treatment different from other treatments for kidney stones?

The ClearPetra Vacuum-assisted Ureteral Access Sheath is unique because it allows for continuous stone fragmentation and removal while maintaining a clear view during the procedure, which can reduce operation time and improve efficiency compared to traditional methods. ^{1 5 9 10 11}

Research Team

Wilson Molina, MD

Principal Investigator

Study Principal Investigator

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

Total stone burden between 1.0 to 2.5 cm

I am scheduled for a specific kidney stone removal surgery.

Exclusion Criteria

I have a bleeding disorder that hasn't been treated.

I am having surgery to remove kidney stones from both sides at once.

Chronic external urinary catheters

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo retrograde intrarenal surgery (RIRS) with either the ClearPetra™ vacuum-assisted ureteral access sheath or a traditional approach

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stone-free status and urinary tract infection postoperatively

90 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• ClearPetra™ Vacuum-assisted Ureteral Access Sheath

Trial Overview 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.

Participant Groups

Group I: 1. RIRS WITH VACUUM-ASSISTED URETERAL ACCESS SHEATH Active Control 1 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 APPROACH Active Control 1 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®)

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

In a study of 136 patients, vacuum-assisted percutaneous nephrolithotomy (Va-PCNL) demonstrated a significantly shorter operative time (95 minutes) compared to standard mini-PCNL (146 minutes), making it a more efficient option for kidney stone treatment.

Both Va-PCNL and mini-PCNL had similar stone-free rates (around 72%) and complication rates, but Va-PCNL resulted in a shorter hospital stay (1.7 days vs. 2.7 days), indicating it may offer advantages in recovery time without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted access sheath in supine mini-percutaneous nephrolithotomy (mini-PCNL). Szczesniewski, JJ., Boronat Catalá, J., García-Cano Fernández, AM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A new method for effective use of the ClearPetra ureteral access sheath for a giant ureteral stone. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

Vacuum-assisted access sheath in supine mini-percutaneous nephrolithotomy (mini-PCNL). [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Vacuum-assisted mini-percutaneous nephrolithotomy: a new perspective in fragments clearance and intrarenal pressure control. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

RIRS with Vacuum-Assisted Ureteral Access Sheath versus MPCNL for the Treatment of 2-4 cm Renal Stone. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Impact of ureteric access sheath use during flexible ureteroscopy: A comparative study on efficacy and safety. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Impact of ureteral access sheath on renal stone treatment: prospective comparative non-randomised outcomes over a 7-year period. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Novel Syphon Ureteral Access Sheath Shows Potential to Reduce Renal Pressures and Improve Irrigant Flow. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Ureteral access strategies: pro-access sheath. [2014]

10. Poland pubmed.ncbi.nlm.nih.gov

Intrarenal pressure and irrigation flow with commonly used ureteric access sheaths and instruments. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

The use of a ureteral access sheath does not improve stone-free rate after ureteroscopy for upper urinary tract stones. [2022]