Kidney StonesNCT06798753
Occlusion Balloon vs. 5FR Ureteral Catheter
A study testing Occlusion Balloon Catheter and 5FR Ureteral Catheter in people with Kidney Stones, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Occlusion Balloon Catheter and 5FR Ureteral Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 29 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Diagnosed with kidney stones and scheduled for PCNL.
- Able and willing to provide informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter
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).
- Conditions
- Kidney Stones
- Being tested
- Occlusion Balloon Catheter, 5FR Ureteral Catheter
- Keywords
- percutaneous nephrolithotomy, PCNL, Occlusion Balloon Catheter, kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusion Balloon CatheterDevice
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.
5FR Ureteral CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Occlusion Balloon Catheter | Active comparator | 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. Receives: Device: Occlusion Balloon Catheter |
| 5FR Ureteral Catheter | Active comparator | 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. Receives: Device: 5FR Ureteral Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Ureteral Stone Fragments Identified Endoscopically
Endoscopic identification of ureteral stone fragments will be used to compare rate of ureteral stone fragments upon completion of PCNL while using OBC versus 5FR-UC.
Measured: During procedure, up to 5 hours
Secondary outcomes (3)
Length of Procedure
Length of procedure is a common procedural outcome of endourologic procedures.
Measured: During procedure, up to 5 hours
Number of Participants With Intraoperative Complications
Number of participants with intraoperative complications, a common procedural outcome of endourologic procedures
Measured: During procedure, up to 5 hours
Number of Participants With Stent Placement
Number of participants with stent placement during procedure
Measured: during procedure, up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start23 Jan 2025
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mantu Gupta, Icahn School of Medicine at Mount Sinai
- Investigators
- Mantu Gupta, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798753
- Sponsor's protocol ID
- STUDY-24-01650
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2025
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results will be shared in aggregate to protect subject privacy