Ureter CalculiNCT07769450
Stone Cone Device vs. Standard URS for Proximal Ureteral Calculi
A study testing Ureteroscopic Pneumatic Lithotripsy with Cone Device and Standard Ureteroscopic Pneumatic Lithotripsy in people with Ureter Calculi, run by Provincial Headquarter Teaching Hospital Gilgit at 1 site in Pakistan.
Trial summary
Retrograde migration of stone fragments into the kidney during ureteroscopic lithotripsy (URS) for proximal ureteral stones is a common technical challenge, occurring in 5-40% of cases. This can lead to residual fragments and lower stone-free rates. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ureter Calculi
- What is being tested?
- Ureteroscopic Pneumatic Lithotripsy with Cone Device and Standard Ureteroscopic Pneumatic Lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A solitary proximal ureteral stone ≤ 2 cm in size as confirmed by imaging.
- Normal renal function.
Who cannot join
- Active urinary tract infection (clinical features or pyuria).
- Bleeding disorder (abnormal prothrombin time or activated partial thromboplastin time).
- Chronic kidney disease (raised urea and creatinine).
- Stone > 2 cm in size.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Provincial Headquarter Teaching Hospital, Gilgit.
Gilgit, Gilgit-Baltistan, 54000
About this study
Official title: A Randomized Controlled Trial Comparing Stone Clearance and Retrograde Migration in Ureteroscopic Pneumatic Lithotripsy for Proximal Ureteral Calculi Performed With and Without the Stone Cone Anti-Retropulsion Device
Retrograde migration of stone fragments into the kidney during ureteroscopic lithotripsy (URS) for proximal ureteral stones is a common technical challenge, occurring in 5-40% of cases. This can lead to residual fragments and lower stone-free rates. The Stone Cone is an anti-retropulsion device designed to trap fragments and prevent their migration. This study will test the hypothesis that the use of the Stone Cone during URS pneumatic lithotripsy will result in a significantly higher stone clearance rate at 48 hours post-procedure compared to the standard technique without the device.
- Conditions
- Ureter Calculi
- Being tested
- Ureteroscopic Pneumatic Lithotripsy with Cone Device, Standard Ureteroscopic Pneumatic Lithotripsy
- Keywords
- Ureteroscopy, Stone Cone Device, Pneumatic Lithotripsy, Stone Clearance, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopic Pneumatic Lithotripsy with Cone DeviceProcedure or surgery
Patients will undergo ureteroscopic pneumatic lithotripsy under general anesthesia. The Stone Cone device (Boston Scientific, Natick, MA) will be advanced through the ureteroscope and positioned fluoroscopically proximal to the calculus before fragmentation. The device will create a mechanical barrier to prevent retrograde stone migration into the renal pelvis and will be used to trap and extract fragments upon withdrawal. A ureteral double-J stent will be placed at the end of the procedure.
Standard Ureteroscopic Pneumatic LithotripsyProcedure or surgery
Patients will undergo standard ureteroscopic pneumatic lithotripsy under general anesthesia without the use of any anti-retropulsion device. Stone fragmentation and fragment extraction will be performed using standard tools (pneumatic lithotripter, grasping forceps, or basket) as per the surgeon's discretion. A ureteral double-J stent will be placed at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Stone Cone Device | Experimental | Participants will undergo ureteroscopic pneumatic lithotripsy for a proximal ureteral calculus. The Stone Cone device will be positioned fluoroscopically proximal to the stone before fragmentation and used to prevent retrograde stone migration and trap fragments for extraction. Receives: Procedure: Ureteroscopic Pneumatic Lithotripsy with Cone Device |
| Group B: Standard URS | Active comparator | Participants will undergo standard ureteroscopic pneumatic lithotripsy for a proximal ureteral calculus without the use of any anti-retropulsion device. Receives: Procedure: Standard Ureteroscopic Pneumatic Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Clearance Rate
The proportion of participants achieving a stone-free status, defined as the absence of stones on plain X-ray of the kidneys, ureters, and bladder (KUB) and abdominal ultrasonography performed 48 hours after the ureteroscopic lithotripsy procedure.
Measured: 48 hours
Secondary outcomes (3)
Incidence of Intraoperative Complications
The number of participants experiencing complications such as ureteral perforation or significant bleeding during the procedure.
Measured: 2 hours
Operative Time
The total duration of the ureteroscopic procedure, measured in minutes.
Measured: 120 minutes
Hospital Stay Duration
The length of the patient's hospital stay following the procedure.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Oct 2022
- Primary completion30 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter CalculiStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provincial Headquarter Teaching Hospital Gilgit
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akbar Shah, Provincial Headquarter Teaching Hospital Gilgit
- Investigators
- Khawar Suliman, MBBS, FCPS, Study director, Provincial Headquarter Teaching Hospital Gilgit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769450
- Sponsor's protocol ID
- PHQ01
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to institutional policies regarding patient confidentiality and data protection. Additionally, the trial is a single-center study with a modest sample size, and the research team does not have an established infrastructure for data-sharing or the necessary resources to support external data requests.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Stone Clearance and Retrograde Migration in Ureteroscopic Pneumatic Lithotripsy for Proximal Ureteral Calculi Performed With and Without the Stone Cone Anti-Retropulsion Device
- ClinicalTrials.gov ID
- NCT07769450
- Acronym / sponsor ID
- PHQ01
- Conditions
- Ureter Calculi
- Keywords
- Ureteroscopy, Stone Cone Device, Pneumatic Lithotripsy, Stone Clearance, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Provincial Headquarter Teaching Hospital GilgitUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrograde migration of stone fragments into the kidney during ureteroscopic lithotripsy (URS) for proximal ureteral stones is a common technical challenge, occurring in 5-40% of cases. This can lead to residual fragments and lower stone-free rates. The Stone Cone is an anti-retropulsion device designed to trap fragments and prevent their migration. This study will test the hypothesis that the use of the Stone Cone during URS pneumatic lithotripsy will result in a significantly higher stone clearance rate at 48 hours post-procedure compared to the standard technique without the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Stone Cone Device | Experimental | Procedure: Ureteroscopic Pneumatic Lithotripsy with Cone DeviceParticipants will undergo ureteroscopic pneumatic lithotripsy for a proximal ureteral calculus. The Stone Cone device will be positioned fluoroscopically proximal to the stone before fragmentation and used to prevent retrograde stone migration and trap fragments for extraction. |
| Group B: Standard URS | Active comparator | Procedure: Standard Ureteroscopic Pneumatic LithotripsyParticipants will undergo standard ureteroscopic pneumatic lithotripsy for a proximal ureteral calculus without the use of any anti-retropulsion device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A solitary proximal ureteral stone ≤ 2 cm in size as confirmed by imaging.
- Normal renal function.
Key exclusion criteria (4 listed)
- Active urinary tract infection (clinical features or pyuria).
- Bleeding disorder (abnormal prothrombin time or activated partial thromboplastin time).
- Chronic kidney disease (raised urea and creatinine).
- Stone > 2 cm in size.
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 |
|---|---|---|
| Ureteroscopic Pneumatic Lithotripsy with Cone DevicePatients will undergo ureteroscopic pneumatic lithotripsy under general anesthesia. The Stone Cone device (Boston Scientific, Natick, MA) will be advanced through the ureteroscope and positioned fluoroscopically proximal to the calculus before fragmentation. The device will create a mechanical barrier to prevent retrograde stone migration into the renal pelvis and will be used to trap and extract fragments upon withdrawal. A ureteral double-J stent will be placed at the end of the procedure. | Procedure or surgery | Group A: Stone Cone Device |
| Standard Ureteroscopic Pneumatic LithotripsyPatients will undergo standard ureteroscopic pneumatic lithotripsy under general anesthesia without the use of any anti-retropulsion device. Stone fragmentation and fragment extraction will be performed using standard tools (pneumatic lithotripter, grasping forceps, or basket) as per the surgeon's discretion. A ureteral double-J stent will be placed at the end of the procedure. | Procedure or surgery | Group B: Standard URS |
Primary outcome
Stone Clearance Rate
Time frame: 48 hours
The proportion of participants achieving a stone-free status, defined as the absence of stones on plain X-ray of the kidneys, ureters, and bladder (KUB) and abdominal ultrasonography performed 48 hours after the ureteroscopic lithotripsy procedure.
3 secondary outcomes
Incidence of Intraoperative Complications
Time frame: 2 hours
Operative Time
Time frame: 120 minutes
Hospital Stay Duration
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to institutional policies regarding patient confidentiality and data protection. Additionally, the trial is a single-center study with a modest sample size, and the research team does not have an established infrastructure for data-sharing or the necessary resources to support external data requests.
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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.
Khawar Suliman, MBBS, FCPS study director
Provincial Headquarter Teaching Hospital Gilgit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopic Pneumatic Lithotripsy with Cone Device and Standard Ureteroscopic Pneumatic Lithotripsy in people with Ureter Calculi, run by Provincial Headquarter Teaching Hospital Gilgit at 1 site in Pakistan.
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 2 inclusion and 4 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 18 Aug 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stone Clearance Rate (time frame: 48 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 18 Aug 2026.