Renal CalculiNCT02734914
Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure
A study testing conventional F-URS in people with Renal Calculi, run by The Affiliated Ganzhou Hospital of Nanchang University.
Trial summary
This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Calculi
- What is being tested?
- conventional F-URS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Aug 2018
- 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
- Subject has provided informed consent and indicated a willingness to comply with study treatments
- Subject has a diagnosis of renal stones according to computer tomography (CT) results
- Subject is 18-75 yrs of age
- Subject has a single stone < 3 cm in size, or multiple stones < 3 cm in cumulative size
- Subject has a serum creatinine level within the normal range for the study center
Who cannot join
- The patient who do not agree with the intention of the clinical study.
- Subject needs bilateral procedures within one-stage ureteroscopy
- Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria
- Subject has been diagnosed with a urethral stricture or bladder neck contracture
- Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
- Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)
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- Subject has other diseases and could not tolerate the endoscopic surgery
- Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
- Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination
About this study
Official title: Safety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study
This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.
Read the detailed description
Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi < 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.
However, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy.
Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.
- Conditions
- Renal Calculi
- Being tested
- SF-URS with automatic control of RPP, conventional F-URS
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF-URS with automatic control of RPPDevice
A new F-URS monitoring and control of RPP using intelligent pressure control device
conventional F-URSDevice
Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.
| Study group | Role | What they receive |
|---|---|---|
| SF-URS with automatic control of RPP | Experimental | Participants in SF-URS with automatic control of renal pelvic pressure (RPP) group undergo ureteroscopy using the intelligent pressure control device (Medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with function of pressure measuring). Receives: Device: SF-URS with automatic control of RPP |
| conventional F-URS | Active comparator | Participants in conventional F-URS group undergo ureteroscopy using the classic flexible ureteroscope. Receives: Device: conventional F-URS |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone-free rate
Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%
Measured: 4 weeks post-operatively
Secondary outcomes (2)
stone-free rate
Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%
Measured: One day post-operatively
Complication rates
Number of participants undergo novel or conventional F-URS surgeries suffer complications associated with the surgery (i.e. pain(NRS≥4), hematuria, T≥38℃, serum white blood cell≥12×〖10〗^9/L ,serum white blood cell<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%
Measured: Within 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Ganzhou Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leming Song, The Affiliated Ganzhou Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734914
- Sponsor's protocol ID
- GanzhouHNU
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study
- ClinicalTrials.gov ID
- NCT02734914
- Acronym / sponsor ID
- GanzhouHNU
- Conditions
- Renal Calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Ganzhou Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- 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 safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.
Detailed description
Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi < 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.
However, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy.
Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SF-URS with automatic control of RPP | Experimental | Device: SF-URS with automatic control of RPPParticipants in SF-URS with automatic control of renal pelvic pressure (RPP) group undergo ureteroscopy using the intelligent pressure control device (Medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with function of pressure measuring). |
| conventional F-URS | Active comparator | Device: conventional F-URSParticipants in conventional F-URS group undergo ureteroscopy using the classic flexible ureteroscope. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has provided informed consent and indicated a willingness to comply with study treatments
- Subject has a diagnosis of renal stones according to computer tomography (CT) results
- Subject is 18-75 yrs of age
- Subject has a single stone < 3 cm in size, or multiple stones < 3 cm in cumulative size
- Subject has a serum creatinine level within the normal range for the study center
Key exclusion criteria (9 listed)
- The patient who do not agree with the intention of the clinical study.
- Subject needs bilateral procedures within one-stage ureteroscopy
- Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria
- Subject has been diagnosed with a urethral stricture or bladder neck contracture
- Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
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 |
|---|---|---|
| SF-URS with automatic control of RPPA new F-URS monitoring and control of RPP using intelligent pressure control device | Device | SF-URS with automatic control of RPP |
| conventional F-URSUreteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi. | Device | conventional F-URS |
Primary outcome
stone-free rate
Time frame: 4 weeks post-operatively
Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%
2 secondary outcomes
stone-free rate
Time frame: One day post-operatively
Complication rates
Time frame: Within 4 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing conventional F-URS in people with Renal Calculi, run by The Affiliated Ganzhou Hospital of Nanchang University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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-free rate (time frame: 4 weeks post-operatively). 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 12 Apr 2016.