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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating kidney stones using a vacuum-assisted device called the ClearPetra™ Vacuum-assisted Ureteral Access Sheath. The researchers aim to determine if this device more effectively removes stones and reduces infections compared to traditional methods. The trial seeks participants with kidney stones between 1 to 2.5 cm who plan to undergo a procedure called flexible ureteroscopy. Participants will either receive the new vacuum device or undergo the standard approach without it. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance kidney stone treatment options.

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 prior data suggests that the ClearPetra™ vacuum-assisted ureteral access sheath is safe for use in treating kidney stones?

Previous studies on the ClearPetra vacuum-assisted ureteral access sheath have shown varying results. The "stone-free rate," or the percentage of patients with no remaining kidney stones, ranged from 71.3% to 97.3%. The "complication rate," indicating how often problems occurred, varied from 13.2% to higher in some cases. While the ClearPetra device has been effective for many, some patients experienced complications.

For safety, the ClearPetra device has been used successfully even without prior stent placement, a step sometimes needed before the main procedure. However, questions about its safety remain, as not all research agrees on the risk of complications. Anyone considering this treatment should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new ClearPetra™ vacuum-assisted ureteral access sheath because it offers a unique approach to removing kidney stones. Unlike traditional methods that rely on standard ureteral access sheaths or none at all, this innovative technique uses a vacuum-assisted mechanism to potentially improve the efficiency and effectiveness of removing stones during RIRS (Retrograde Intrarenal Surgery). The vacuum assistance might reduce procedure time and increase stone clearance rates, which could lead to quicker recovery and less discomfort for patients. This method represents a promising advancement in the management of kidney stones, potentially enhancing outcomes compared to the conventional approaches.

What evidence suggests that the ClearPetra device is effective for kidney stones?

Research has shown that the ClearPetra device, which participants in this trial may receive, effectively treats kidney stones. Studies have found that it reduces the risk of post-surgery fever, speeds up the procedure, and increases the number of patients who are stone-free afterward. The device enables continuous breaking and removal of stones, offering greater efficiency than traditional methods. Additionally, using this device can result in fewer infections after the procedure. Overall, ClearPetra offers advantages over traditional methods for removing kidney stones. ^{1 3 5 6 7}

Who Is on the Research Team?

Wilson Molina, MD

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

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.

Chronic external urinary catheters

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. liebertpub.com liebertpub.com/doi/pdf/10.1089/lap.2024.0076?download=true

Efficacy of Aspiration-Assisted Ureteral Access Sheath ( ... Moreover, we can say that the use of ClearPETRA in RIRS, especially for stones larger than 2 cm, reduces the operation time, increases the SFR, and also reduces ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38546503/

Efficacy of Aspiration-Assisted Ureteral Access Sheath ... Conclusion: We found that ClearPETRA reduces the likelihood of postoperative fever after RIRS surgeries. Moreover, we can say that the use of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06547632

ClearPetra™ Vacuum-assisted Ureteral Access Sheath Vs ... The new ClearPetra™ vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones. It is a disposable access sheath ...

4. tau.amegroups.org tau.amegroups.org/article/view/138715/html

Impact of suction ureteral access sheath in ureteroscopy ... Using suction ureteral access sheaths (SUASs) during endoscopic stone surgery improves short-term stone-free rates (SFRs), shortens surgical ...

5. goldjournal.net goldjournal.net/article/S0090-4295(25)00748-4/abstract

First Prospective, In Vivo Experience Using a Novel ... The ClearPetra UAS was used successfully in all patients despite only 31% being pre-stented. Only 12 cases required a basket. There were 9 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11084567/

Assessment of Effectiveness and Safety of Aspiration-Assisted ... The reported stone-free rate (SFR) for vacuum-assisted Clear Petra miniPCNL procedures ranged from 71.3% to 97.3%, while the complication rates varied from 13.2 ...

7. withpower.com withpower.com/trial/phase-nephrolithiasis-8-2024-90d29

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