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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter
- ClinicalTrials.gov ID
- NCT06798753
- Acronym / sponsor ID
- STUDY-24-01650
- Conditions
- Kidney Stones
- Keywords
- percutaneous nephrolithotomy, PCNL, Occlusion Balloon Catheter, kidney stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Posted 20 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusion Balloon Catheter | Active comparator | Device: Occlusion Balloon CatheterThe 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 Catheter | Active comparator | Device: 5FR Ureteral CatheterThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older.
- Diagnosed with kidney stones and scheduled for PCNL.
- Able and willing to provide informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusion Balloon CatheterThe 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. | Device | Occlusion Balloon Catheter |
| 5FR Ureteral CatheterThe 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. | Device | 5FR Ureteral Catheter |
Primary outcome
Number of Participants With Ureteral Stone Fragments Identified Endoscopically
Time frame: During procedure, up to 5 hours
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.
3 secondary outcomes
Length of Procedure
Time frame: During procedure, up to 5 hours
Number of Participants With Intraoperative Complications
Time frame: During procedure, up to 5 hours
Number of Participants With Stent Placement
Time frame: during procedure, up to 5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Results will be shared in aggregate to protect subject privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mantu Gupta, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Ureteral Stone Fragments Identified Endoscopically (time frame: During procedure, up to 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.