Kidney StoneNCT06729801
Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery
A study testing IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) and Conventional FANS in people with Kidney Stone, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) and Conventional FANS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 7 Jan 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-75 years old) diagnosed with renal stones (size ≤4 cm) and suitable for retrograde intrarenal surgery (RIRS).
- Willing to provide informed consent.
- No significant renal, cardiac, or systemic diseases that may interfere with the surgical procedure or the study.
- Preoperative intravenous pyelography (IVP) showing no significant ureteral stricture.
Who cannot join
- Patients with active urinary tract infections (UTIs) or fever at the time of surgery.
- Pregnancy or breastfeeding women.
- Patients with a history of severe renal disease (e.g., chronic kidney disease stage 3 or higher).
- History of prior ureteral or renal surgery that may affect the anatomy.
- Patients with uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.
- Patients who are unwilling or unable to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Pilot Clinical Study
This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. The primary outcomes include IRP monitoring accuracy, operative time, stone-free rate (SFR), and complication rates, with the aim of improving stone retrieval efficiency and procedural safety in RIRS. This trial seeks to validate the innovative device's role in expanding RIRS indications, especially for large renal stones.
- Conditions
- Kidney Stone
- Being tested
- IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS), Conventional FANS
- Keywords
- RIRS, FANS
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS)Device
The IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a novel device designed to enable real-time monitoring of intrarenal pressure (IRP) during retrograde intrarenal surgery (RIRS). It incorporates a pressure-sensing port connected to a gas conduit embedded in the sheath, which allows the surgeon to adjust irrigation flow and suction pressure based on real-time IRP readings, thereby optimizing stone retrieval efficiency while ensuring safety by maintaining a safe IRP range. The device improves surgical outcomes, particularly in complex cases involving larger renal stones, by reducing operative time and minimizing the risk of complications.
Conventional FANSDevice
The Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a standard device used in retrograde intrarenal surgery (RIRS) for stone retrieval. Unlike the IRP-monitoring version, this device does not provide real-time monitoring of intrarenal pressure (IRP). Irrigation flow and suction pressure are pre-set and adjusted based on clinical protocols. It facilitates the removal of renal stones through a flexible and navigable design, but without the added capability of monitoring and adjusting IRP during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| IRP-Monitoring FANS Group | Experimental | Patients in this group will undergo retrograde intrarenal surgery (RIRS) using the intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS). This novel device provides real-time IRP monitoring, enabling the surgeon to adjust intraoperative irrigation and suction settings to optimize stone retrieval efficiency while maintaining IRP within a safe range. Receives: Device: IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) |
| Conventional FANS Group | Active comparator | Patients in this group will undergo RIRS using a conventional flexible and navigable suction ureteral access sheath (FANS) without intrarenal pressure (IRP) monitoring. The irrigation flow rate and suction pressure will be pre-set and adjusted based on standard clinical practices. Receives: Device: Conventional FANS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
The primary outcome will be the total operative time, measured from the insertion of the endoscope into the urethra to the completion of stent placement. This outcome will assess the efficiency of stone retrieval when using either the IRP-monitoring FANS or the conventional FANS.
Measured: Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).
Secondary outcomes (2)
Stone-Free Rate (SFR)
The stone-free rate (SFR) will be measured postoperatively through non-contrast CT imaging. The SFR will assess the effectiveness of stone retrieval and the success of the procedure.
Measured: 24-48 hours post-surgery, based on CT scan results.
Postoperative Complications
The rate of postoperative complications, including fever, infection, bleeding, or ureteral injury, will be recorded. This will help compare the safety profile of both FANS devices.
Measured: Evaluated within 30 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729801
- Sponsor's protocol ID
- MERE2024-003
- Status last verified
- Jan 2025
- First submitted
- 7 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT06729801
- Acronym / sponsor ID
- MERE2024-003
- Conditions
- Kidney Stone
- Keywords
- RIRS, FANS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 11 Dec 2024 (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.
This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. The primary outcomes include IRP monitoring accuracy, operative time, stone-free rate (SFR), and complication rates, with the aim of improving stone retrieval efficiency and procedural safety in RIRS. This trial seeks to validate the innovative device's role in expanding RIRS indications, especially for large renal stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRP-Monitoring FANS Group | Experimental | Device: IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS)Patients in this group will undergo retrograde intrarenal surgery (RIRS) using the intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS). This novel device provides real-time IRP monitoring, enabling the surgeon to adjust intraoperative irrigation and suction settings to optimize stone retrieval efficiency while maintaining IRP within a safe range. |
| Conventional FANS Group | Active comparator | Device: Conventional FANSPatients in this group will undergo RIRS using a conventional flexible and navigable suction ureteral access sheath (FANS) without intrarenal pressure (IRP) monitoring. The irrigation flow rate and suction pressure will be pre-set and adjusted based on standard clinical practices. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18-75 years old) diagnosed with renal stones (size ≤4 cm) and suitable for retrograde intrarenal surgery (RIRS).
- Willing to provide informed consent.
- No significant renal, cardiac, or systemic diseases that may interfere with the surgical procedure or the study.
- Preoperative intravenous pyelography (IVP) showing no significant ureteral stricture.
Key exclusion criteria (6 listed)
- Patients with active urinary tract infections (UTIs) or fever at the time of surgery.
- Pregnancy or breastfeeding women.
- Patients with a history of severe renal disease (e.g., chronic kidney disease stage 3 or higher).
- History of prior ureteral or renal surgery that may affect the anatomy.
- Patients with uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.
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 |
|---|---|---|
| IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS)The IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a novel device designed to enable real-time monitoring of intrarenal pressure (IRP) during retrograde intrarenal surgery (RIRS). It incorporates a pressure-sensing port connected to a gas conduit embedded in the sheath, which allows the surgeon to adjust irrigation flow and suction pressure based on real-time IRP readings, thereby optimizing stone retrieval efficiency while ensuring safety by maintaining a safe IRP range. The device improves surgical outcomes, particularly in complex cases involving larger renal stones, by reducing operative time and minimizing the risk of complications. | Device | IRP-Monitoring FANS Group |
| Conventional FANSThe Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a standard device used in retrograde intrarenal surgery (RIRS) for stone retrieval. Unlike the IRP-monitoring version, this device does not provide real-time monitoring of intrarenal pressure (IRP). Irrigation flow and suction pressure are pre-set and adjusted based on clinical protocols. It facilitates the removal of renal stones through a flexible and navigable design, but without the added capability of monitoring and adjusting IRP during the procedure. | Device | Conventional FANS Group |
Primary outcome
Operative Time
Time frame: Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).
The primary outcome will be the total operative time, measured from the insertion of the endoscope into the urethra to the completion of stent placement. This outcome will assess the efficiency of stone retrieval when using either the IRP-monitoring FANS or the conventional FANS.
2 secondary outcomes
Stone-Free Rate (SFR)
Time frame: 24-48 hours post-surgery, based on CT scan results.
Postoperative Complications
Time frame: Evaluated within 30 days post-surgery.
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 17 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) and Conventional FANS in people with Kidney Stone, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 4 inclusion and 6 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 17 Jan 2025. 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 China. 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?
Operative Time (time frame: Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).). 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 17 Jan 2025.