N/A
Completed N=108
Occlusion Balloon vs. 5FR Ureteral Catheter
Source: ClinicalTrials.gov NCT06798753 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Number of Participants With Ureteral Stone Fragments Identified Endoscopically — 2; 8 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ureteral Stone Fragments Identified Endoscopically |
2; 8 | — |
| SECONDARY Length of Procedure |
100; 90 | — |
| SECONDARY Number of Participants With Intraoperative Complications |
0; 0 | — |
| SECONDARY Number of Participants With Stent Placement |
22; 23 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT06798753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.