Occlusion Balloon vs. Ureteral Catheter for Kidney Stones

Overseen By Blair Gallante, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Pregnancy, Urinary tract anomalies, others

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

Compensation: Varies

Number of Visits: 1

Duration: During procedure

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an occlusion balloon catheter (a small tube with an inflatable tip) during kidney stone removal surgery can prevent stone fragments from moving into the ureter. It compares this method to a standard ureteral catheter (a thin tube inserted into the ureter) to determine which better controls stone fragments. Individuals diagnosed with kidney stones and scheduled for a specific type of surgery called PCNL (a procedure to remove kidney stones) might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for kidney stone patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these devices are safe for use in kidney stone procedures?

Research has shown that the occlusion balloon catheter is generally well-tolerated by patients undergoing kidney stone procedures. One study found that using this catheter before kidney stone removal surgery improved the success rate in 60 out of 71 patients, particularly those with specific types of stones. This study reported no major safety issues.

The 5FR ureteral catheter is frequently used during kidney stone procedures to enhance visibility and assist in surgery. Studies generally indicate it is safe and effective in these situations, with no significant adverse events reported in the reviewed data.

Both devices appear safe based on current research, with no major complications reported. However, as with any medical procedure, some risk remains. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Occlusion Balloon Catheter because it offers a unique approach to managing kidney stones compared to the standard ureteral catheters. Unlike the typical 5FR ureteral catheter, which is primarily used for visualization and access, the Occlusion Balloon Catheter features an inflatable balloon. This balloon can prevent the migration of stone fragments during procedures, potentially reducing the risk of complications and improving surgical outcomes. By targeting stone migration directly, the Occlusion Balloon Catheter could enhance the safety and effectiveness of kidney stone treatments.

What evidence suggests that the occlusion balloon catheter is effective for preventing stone migration during kidney stone treatment?

This trial will compare the effectiveness of an Occlusion Balloon Catheter with a 5FR Ureteral Catheter for kidney stone removal. Research has shown that using an occlusion balloon catheter can improve the success of kidney stone removal procedures. One study found that using these catheters before a procedure called nephrostomy increased success rates in 60 out of 71 patients. The catheter temporarily blocks the kidney's exit, preventing stone pieces from moving into the ureter, the tube that carries urine to the bladder. This method is particularly helpful for patients with stones in the kidney's central area and expanded drainage systems. Overall, the occlusion balloon catheter can enhance stone removal by preventing fragments from causing additional problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Mantu Gupta, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Adults over 18 with kidney stones who are scheduled for a type of surgery called PCNL can join. They must be able to consent. Those with urinary tract anomalies, previous related surgeries, or pregnant women cannot participate.

Inclusion Criteria

I have kidney stones and am scheduled for a PCNL procedure.

Able and willing to provide informed consent

Exclusion Criteria

I have had surgery or have a condition affecting my urinary system.

Pregnant women

I can undergo procedures lying face down.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous nephrolithotomy (PCNL) with either an occlusion balloon catheter or a 5FR ureteral catheter

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for the presence of ureteral stone fragments and procedural outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 5FR Ureteral Catheter
• Occlusion Balloon Catheter

Trial Overview

The study is testing if using an occlusion balloon catheter during a specific kind of kidney stone surgery (supine PCNL) prevents stone fragments from moving into the ureter better than a standard ureteral catheter.

How Is the Trial Designed?

Group I: Occlusion Balloon Catheter Active Control 1 Intervention

The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.

Group II: 5FR Ureteral Catheter Active Control 1 Intervention

The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Transrenal ureteral occlusion was performed on 83 ureters in 76 patients, showing that detachable latex balloons were more effective than tissue adhesive, with 69% of balloon occlusions being permanently sealed after one procedure compared to 55% for tissue adhesive.

The average duration of effective occlusion was significantly longer with detachable balloons (19.5 weeks) compared to tissue adhesive (2.5 weeks), and the procedure was generally safe, with only 7% of interventions resulting in complications, most of which were minor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transrenal ureteral occlusion: results and problems. Schild, HH., Günther, R., Thelen, M.[2019]

Inserting occlusion balloon catheters before nephrostomy in 60 out of 71 patients improved the success rate of percutaneous renal calculus removal, especially in complex cases like ureteral and infundibular calculi.

Applying hydrostatic pressure overnight in 23 patients with challenging stone conditions led to significant dilation of the renal pelvis, facilitating better access and manipulation of stones during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of retrograde occlusion balloon catheters in percutaneous removal of renal calculi. Beckmann, CF., Roth, RA.[2019]

In a study of 44 patients with ureteral stones, single-stage percutaneous nephrolithotomy was highly effective, achieving success in 42 cases, demonstrating its efficacy as a treatment method.

The use of an occlusion balloon catheter improved the procedure by allowing better visualization for renal puncture, and techniques like mechanical pushing or flushing of stones were successful in 24 out of 30 patients, indicating that these methods can enhance stone removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper and midureteral calculi: percutaneous extraction with an occlusion balloon catheter. Beckmann, CF., Roth, RA., Luedke, MD.[2016]

In a study of 413 patients who underwent peri-operative ureteral catheter placement, 12.1% experienced urologic complications within 30 days, indicating a notable risk associated with the procedure.

The study found that intraoperative difficulty in catheter placement was significantly linked to higher-grade complications, highlighting the importance of technique in minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications Of Peri-Operative Ureteral Catheter Placement: Experience at A Major Cancer Center. Geskin, AA., Westney, OL., Graber, WJ., et al.[2023]

The use of an antegrade occlusion balloon catheter in 8 out of 21 patients with proximal ureteral stones effectively prevented stone migration during endoscopic treatment, leading to successful stone removal in all cases.

This technique is particularly beneficial for patients with significant dilation of the proximal collecting system or those who have had previous unsuccessful interventions, enhancing the overall success rate of ureteroscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ureteroscopic treatment of proximal ureter stones with the aid of an antegrade occlusion balloon catheter. Dirim, A., Tekin, MI., Aytekin, C., et al.[2019]

In a study of 195 patients with proximal ureteric stones, the Stone Cone device significantly reduced the incidence of stone migration during ureteroscopic pneumatic lithotripsy compared to the N-Trap and control groups, leading to a higher stone-free rate of 95.24%.

Both ureteral occlusive devices (Stone Cone and N-Trap) effectively decreased the occurrence of residual stone fragments, ureteral trauma, and the need for additional procedures, but the Stone Cone was notably more effective in preventing stone migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized prospective controlled study for assessment of different ureteral occlusion devices in prevention of stone migration during pneumatic lithotripsy. Farahat, YA., Elbahnasy, AE., Elashry, OM.[2011]

In a study of 59 patients with upper ureteral stones, a new stone occlusion device was found to be as effective and safe as the established NTrap device during laser lithotripsy, with no complications reported in either group.

Both devices showed identical operation times and success rates, but the new device is more cost-effective, being available at half the price of NTrap, suggesting it could be a viable alternative for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new stone occlusion device for upper ureteral calculi: preliminary clinical outcomes. Feng, CC., Wu, Z., Jiang, HW., et al.[2012]

The use of an occlusion balloon catheter during the percutaneous removal of kidney stones significantly improves the success rate of nephrostomy procedures.

This technique also enhances the effectiveness of stone fragment removal, potentially leading to better patient outcomes in kidney stone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of occlusion balloon catheter in percutaneous renal stone extraction. Littleton, RH., Cerny, JC., Miles, B.[2019]

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Use of retrograde occlusion balloon catheters in ...

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Occlusion Balloon vs. Ureteral Catheter for Kidney Stones

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Occlusion Balloon vs. 5FR Ureteral Catheter

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Purpose: To evaluate the clinical efficacy, safety, and costs of percutaneous occlusive balloon catheter-assisted ureteroscopic lithotripsy (POBC-URSL) for ...

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A prospective, single-centered, cohort study comparing the ...

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Aim of the Study is to compare results, safety and outcome of Ultra mini PCNL versus stented extracorporeal shock wave lithotripsy (SWL) for the management of ...

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