Occlusion Balloon vs. Ureteral Catheter for Kidney Stones
Recruiting in Palo Alto (17 mi)
Overseen byMantu Gupta, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Disqualifiers: Pregnancy, Urinary tract anomalies, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).
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 data supports the effectiveness of this treatment for kidney stones?
Research shows that using an occlusion balloon catheter can improve the success of kidney stone removal by preventing stone migration and enhancing the removal process. Additionally, ureteral catheters help in dilating the urinary tract, making it easier to remove stones.
12345Is the use of occlusion balloon catheters and ureteral catheters generally safe for humans?
The use of occlusion balloon catheters and ureteral catheters is generally considered safe in humans, as they have been used successfully in procedures to remove kidney stones, enhancing the success of these procedures without significant safety concerns.
12367How does the occlusion balloon catheter treatment for kidney stones differ from other treatments?
The occlusion balloon catheter is unique because it helps prevent stone migration and enhances the removal of kidney stones by dilating the ureter and improving access during procedures. This approach can increase the success rate of stone removal compared to traditional methods.
12348Eligibility Criteria
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.
I am 18 years old or older.
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Occlusion Balloon CatheterActive Control1 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 CatheterActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount Sinai WestNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
Use of occlusion balloon catheter in percutaneous renal stone extraction. [2019]Using an occlusion balloon catheter during percutaneous removal of renal calculi can increase the success of obtaining a nephrostomy as well as enhance the removal of stone fragments.
Ureteroscopic treatment of proximal ureter stones with the aid of an antegrade occlusion balloon catheter. [2019]To define the role of an antegrade occlusion balloon catheter in preventing migration of proximal ureteral stones to the dilated proximal ureter during endoscopic treatment.
Use of retrograde occlusion balloon catheters in percutaneous removal of renal calculi. [2019]The best results in percutaneous renal calculus removal are in patients with solitary pelvic stones and dilated collecting systems. Calyceal and/or infundibular calculi and ureteral calculi constitute more complex problems and are less successfully removed. Placement failure of the nephrostomy tube, and inability to gain access to calyceal calculi, and to engage impacted stones are the usual causes for unsuccessful procedures. To try to improve overall success we inserted occlusion balloon catheters prior to nephrostomy insertion in 60 of 71 patients. In a select group of 23 patients with a small renal pelvis and large calculi or infundibular calculi or patients with ureteral calculi, overnight application of 20 cm of hydrostatic pressure through the ureteric catheter led to marked dilatation in all instances. In all other patients the occlusion balloon catheter was placed immediately prior to the definitive nephrostolithotomy procedure. These ureteral catheters allow for better opacification and for dilatation of a small collecting system thereby facilitating the placement of the nephrostomy tube. They permit manipulation of calyceal and especially ureteral calculi. Placement of ureteral occlusion catheters is a safe adjunct to nephrostolithotomies and, in our experience, resulted in increased overall success.
Upper and midureteral calculi: percutaneous extraction with an occlusion balloon catheter. [2016]In 44 patients with one or more calculi in the upper two-thirds of the ureter, single-stage percutaneous nephrolithotomy was performed through a middle or upper calyceal nephrostomy after cystoscopic placement of an occlusion balloon catheter distal to the calculus; in 42, the procedure was successful. The occlusion balloon catheter permitted retrograde opacification of all systems for enhanced renal puncture. In the last 30 patients an attempt was made either to push the calculus upward mechanically or to flush it upward into the renal pelvis with carbon dioxide or dilute contrast material. This was successful in 24 of these patients. Prior overnight occlusion of the ureter by means of ureteral dilatation further facilitates dislodgment of the calculus, which was successful in 12 of 13 patients.
Transrenal ureteral occlusion: results and problems. [2019]The effectiveness of transrenal ureteral occlusion was evaluated.
Complications Of Peri-Operative Ureteral Catheter Placement: Experience at A Major Cancer Center. [2023]To evaluate risks of peri-operative ureteral catheter placement in a consecutive patient-series.
A new stone occlusion device for upper ureteral calculi: preliminary clinical outcomes. [2012]To evaluate the efficacy and safety of the newly developed stone occlusion device in preventing retropulsion of upper ureteral calculi during laser lithotripsy.
A randomized prospective controlled study for assessment of different ureteral occlusion devices in prevention of stone migration during pneumatic lithotripsy. [2011]To compare the safety and efficacy of two different ureteral occlusion devices (stone cone and entrapment net) in preventing retrograde stone migration during ureteroscopic pneumatic lithotripsy. Proximal migration of stone fragments during ureteroscopic lithotripsy is a common problem, especially when the pneumatic lithotripter is used for stone fragmentation.