Comparing two methods for preventing kidney stone migration during surgery
The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter
This study is testing if using a special balloon catheter during kidney stone surgery can help keep stone pieces from moving into the ureter better than a standard catheter.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06798753 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of an Occlusion Balloon catheter versus a 5FR Ureteral Catheter during percutaneous nephrolithotomy (PCNL) for patients with kidney stones. The Occlusion Balloon catheter is designed to occlude the exit of the kidney pelvis, potentially preventing the migration of stone fragments into the ureter. The study aims to determine whether using the Occlusion Balloon catheter reduces the presence of ureteral stone fragments after the procedure compared to the standard catheter. Participants will be adults diagnosed with kidney stones who are scheduled for PCNL.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with kidney stones and scheduled for percutaneous nephrolithotomy.
Not a fit: Patients who may not benefit include those with urinary tract anomalies or those undergoing the procedure in a prone position.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing kidney stone removal.
How similar studies have performed: While the use of occlusion balloons in similar procedures has been explored, this specific comparison is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older. * Diagnosed with kidney stones and scheduled for PCNL. * Able and willing to provide informed consent. Exclusion Criteria: * Pregnant women * Urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum. * Prone procedure
Where this trial is running
New York, New York
- Mount Sinai West — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mantu Gupta, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Blair Gallante, MPH
- Email: blair.gallante@mountsinai.org
- Phone: 631-991-1159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.