Renal CalculiNCT02426931
Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy in Renal Calculi
A study testing the tip-flexible ureterorenoscope and the classic flexible ureteroscope in people with Renal Calculi, run by Ling Li, MD.
Trial summary
This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial 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?
- the tip-flexible ureterorenoscope and the classic flexible ureteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2015
- 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) and intravenous pyelogram (IVP) results
- Subject is a surgical candidate for the ureteroscopic approach
- Subject is 18-80 yrs of age
- Subject has a single stone < 3 cm in size (IVP), or multiple stones < 3 cm in cumulative size (IVP)
- Subject has a serum creatinine level within the normal range for the study center
Who cannot join
- Subject needs bilateral procedures within one-stage ureteroscopy
- Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
- Subject has been diagnosed with a urethral stricture or bladder neck contracture
- Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
- Subject has severe hematuria that might blur the vision of the endoscopy
- Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
Show all 11Show fewer
- Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)
- 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 ipsilateral pre-stenting or previous ureteroscopy within six months
- Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy for the Treatment of Renal Calculi < 3 cm - Efficacity Prospective Randomized Multicentre Trial
This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.
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, some limitations still remain. Poor maneuverability, extra costs for the ureteral access sheath, and high device vulnerability still preclude flexible ureteroscopy from wider distribution.
Recently, the investigators present a novel ureterorenoscope, which is composed of a retractable rigid sheath and a semi-rigid ureteroscope with a flexible part on the tip. When the flexible tip of the inner shaft maintains within the sheath, working in the "rigid mode", the tip-flexible semi-rigid ureterorenoscope is capable of passing either the orifice or the physiological tortuosity of the ureter with ease. When the inner shaft is extended beyond the sheath, the endoscope is switched to the "flexible mode", capable of performing an intrarenal approach.
This endoscope integrates the classic semi-rigid and flexible ureteroscope both structurally and functionally, and has been approved for clinical application by the China Food and Drug Administration. In this study, transverse comparison is designed to evaluate the safety and efficacy of the tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi.
- Conditions
- Renal Calculi
- Being tested
- the tip-flexible ureterorenoscope, the classic flexible ureteroscope
- Keywords
- retrograde intrarenal surgery, flexible ureteroscopy, renal calculi
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the tip-flexible ureterorenoscopeDevice
Ureteroscopy will be conducted using the tip-flexible semi-rigid ureterorenoscope to treat renal calculi. Holmium laser and basket can be used to perform the technique.
the classic flexible ureteroscopeDevice
Ureteroscopy will be conducted using the classic flexible ureteroscope (Flex x2 STORZ, Germany) to treat renal calculi. Holmium laser and basket can be used to perform the technique.
| Study group | Role | What they receive |
|---|---|---|
| tf-URS | Experimental | Participants in tf-URS group undergo ureteroscopy using the tip-flexible ureterorenoscope. Receives: Device: the tip-flexible ureterorenoscope |
| f-URS | Active comparator | Participants in f-URS group undergo ureteroscopy using the classic flexible ureteroscope. Receives: Device: the classic flexible ureteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance
Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%
Measured: 12 weeks post-operatively
Secondary outcomes (5)
Stone clearance
Number of participants undergo tf-URS or 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 tf-URS or f-URS surgeries suffer complications associated with the surgery (i.e. painess(NRS≥4), hematuria, T≥38℃, serum WBC≥12×〖10〗^9/L ,serum WBC<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%
Measured: Within 12 weeks after surgery
Endoscope deflection loss rates
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with deflection loss>10%/Total number of ureterorenoscope or ureterosocpe used *100%
Measured: intraoperative
Endoscope Leakage rates
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with leakage of the working channel or the outer shaft/times of the ureterorenoscope or ureterosocpe used *100%
Measured: intraoperative
Endoscope black dots rates
Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with black dots on endoscopic images/times of ureterorenoscope or ureterosocpe used *100%
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ling Li, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xiangya Hospital of Central South University, Ningbo No. 1 Hospital, West China Hospital, Beijing Tsinghua Changgeng Hospital, Yantai Yuhuangding Hospital
- Responsible party
- Sponsor-investigator, Ling Li, MD, Changhai Hospital
- Investigators
- Yinghao Sun, MD, Study chair, Changhai HospitalGuohua Zeng, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical UniversityHequn Chen, MD, Principal investigator, Xiangya Hospital of Central South UniversityYue Cheng, MD, Principal investigator, Ningbo No. 1 HospitalKunjie Wang, MD, Principal investigator, West China HospitalJianxing Li, MD, Principal investigator, Beijing Tsinghua Changgeng HospitalLei Shi, MD, Principal investigator, Yantai Yuhuangding HospitalXiaofeng Gao, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426931
- Sponsor's protocol ID
- 01
- Status last verified
- Apr 2015
- First submitted
- 12 Feb 2015
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Epub 2012 Jul 30.
PubMed 22642568de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.
PubMed 24147820Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3.
PubMed 24890883Yoon PD, Chalasani V, Woo HH. Use of Clavien-Dindo classification in reporting and grading complications after urological surgical procedures: analysis of 2010 to 2012. J Urol. 2013 Oct;190(4):1271-4. doi: 10.1016/j.juro.2013.04.025. Epub 2013 Apr 11.
PubMed 23583859Yinghao S, Yang B, Gao X. The management of renal caliceal calculi with a newly designed ureteroscope: a rigid ureteroscope with a deflectable tip. J Endourol. 2010 Jan;24(1):23-6. doi: 10.1089/end.2009.0030.
PubMed 20059383Rebuck DA, Macejko A, Bhalani V, Ramos P, Nadler RB. The natural history of renal stone fragments following ureteroscopy. Urology. 2011 Mar;77(3):564-8. doi: 10.1016/j.urology.2010.06.056. Epub 2010 Dec 15.
PubMed 21109293Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.
PubMed 22982421Atis G, Arikan O, Gurbuz C, Yildirim A, Erol B, Pelit S, Ulus I, Caskurlu T. Comparison of different ureteroscope sizes in treating ureteral calculi in adult patients. Urology. 2013 Dec;82(6):1231-5. doi: 10.1016/j.urology.2013.07.021. Epub 2013 Sep 12.
PubMed 24035032Perez Castro E, Osther PJ, Jinga V, Razvi H, Stravodimos KG, Parikh K, Kural AR, de la Rosette JJ; CROES Ureteroscopy Global Study Group. Differences in ureteroscopic stone treatment and outcomes for distal, mid-, proximal, or multiple ureteral locations: the Clinical Research Office of the Endourological Society ureteroscopy global study. Eur Urol. 2014 Jul;66(1):102-9. doi: 10.1016/j.eururo.2014.01.011. Epub 2014 Jan 23.
PubMed 24507782Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72.
PubMed 25361706Wendt-Nordahl G, Mut T, Krombach P, Michel MS, Knoll T. Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors? Urol Res. 2011 Jun;39(3):185-8. doi: 10.1007/s00240-010-0331-0. Epub 2010 Nov 5.
PubMed 21052986Wendt-Nordahl G, Trojan L, Alken P, Michel MS, Knoll T. Ureteroscopy for stone treatment using new 270 degrees semiflexible endoscope: in vitro, ex vivo, and clinical application. J Endourol. 2007 Dec;21(12):1439-44. doi: 10.1089/end.2006.0291.
PubMed 18186680Geavlete P, Multescu R, Geavlete B. Retrograde flexible ureteroscopic approach of upper urinary tract pathology: What is the status in 2014? Int J Urol. 2014 Nov;21(11):1076-84. doi: 10.1111/iju.12582. Epub 2014 Aug 1.
PubMed 25081354Bedke J, Leichtle U, Lorenz A, Nagele U, Stenzl A, Kruck S. 1.2 French stone retrieval baskets further enhance irrigation flow in flexible ureterorenoscopy. Urolithiasis. 2013 Apr;41(2):153-7. doi: 10.1007/s00240-012-0540-9. Epub 2013 Jan 5.
PubMed 23503877Somani BK, Al-Qahtani SM, de Medina SD, Traxer O. Outcomes of flexible ureterorenoscopy and laser fragmentation for renal stones: comparison between digital and conventional ureteroscope. Urology. 2013 Nov;82(5):1017-9. doi: 10.1016/j.urology.2013.07.017. Epub 2013 Aug 31.
PubMed 24001703
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy for the Treatment of Renal Calculi < 3 cm - Efficacity Prospective Randomized Multicentre Trial
- ClinicalTrials.gov ID
- NCT02426931
- Acronym / sponsor ID
- 01
- Conditions
- Renal Calculi
- Keywords
- retrograde intrarenal surgery, flexible ureteroscopy, renal calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ling Li, MDUniversity, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xiangya Hospital of Central South University, Ningbo No. 1 Hospital, West China Hospital, Beijing Tsinghua Changgeng Hospital, Yantai Yuhuangding Hospital
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 27 Apr 2015 (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 novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.
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, some limitations still remain. Poor maneuverability, extra costs for the ureteral access sheath, and high device vulnerability still preclude flexible ureteroscopy from wider distribution.
Recently, the investigators present a novel ureterorenoscope, which is composed of a retractable rigid sheath and a semi-rigid ureteroscope with a flexible part on the tip. When the flexible tip of the inner shaft maintains within the sheath, working in the "rigid mode", the tip-flexible semi-rigid ureterorenoscope is capable of passing either the orifice or the physiological tortuosity of the ureter with ease. When the inner shaft is extended beyond the sheath, the endoscope is switched to the "flexible mode", capable of performing an intrarenal approach.
This endoscope integrates the classic semi-rigid and flexible ureteroscope both structurally and functionally, and has been approved for clinical application by the China Food and Drug Administration. In this study, transverse comparison is designed to evaluate the safety and efficacy of the tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tf-URS | Experimental | Device: the tip-flexible ureterorenoscopeParticipants in tf-URS group undergo ureteroscopy using the tip-flexible ureterorenoscope. |
| f-URS | Active comparator | Device: the classic flexible ureteroscopeParticipants in 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 (6 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) and intravenous pyelogram (IVP) results
- Subject is a surgical candidate for the ureteroscopic approach
- Subject is 18-80 yrs of age
- Subject has a single stone < 3 cm in size (IVP), or multiple stones < 3 cm in cumulative size (IVP)
Key exclusion criteria (11 listed)
- Subject needs bilateral procedures within one-stage ureteroscopy
- Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
- Subject has been diagnosed with a urethral stricture or bladder neck contracture
- Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
- Subject has severe hematuria that might blur the vision of the endoscopy
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 |
|---|---|---|
| the tip-flexible ureterorenoscopeUreteroscopy will be conducted using the tip-flexible semi-rigid ureterorenoscope to treat renal calculi. Holmium laser and basket can be used to perform the technique. | Device | tf-URS |
| the classic flexible ureteroscopeUreteroscopy will be conducted using the classic flexible ureteroscope (Flex x2 STORZ, Germany) to treat renal calculi. Holmium laser and basket can be used to perform the technique. | Device | f-URS |
Primary outcome
Stone clearance
Time frame: 12 weeks post-operatively
Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%
5 secondary outcomes
Stone clearance
Time frame: One day post-operatively
Complication rates
Time frame: Within 12 weeks after surgery
Endoscope deflection loss rates
Time frame: intraoperative
Endoscope Leakage rates
Time frame: intraoperative
Endoscope black dots rates
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Background: PubMed 22642568Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Epub 2012 Jul 30.
- Background: PubMed 24147820de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.
- Background: PubMed 24890883Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3.
- Background: PubMed 23583859Yoon PD, Chalasani V, Woo HH. Use of Clavien-Dindo classification in reporting and grading complications after urological surgical procedures: analysis of 2010 to 2012. J Urol. 2013 Oct;190(4):1271-4. doi: 10.1016/j.juro.2013.04.025. Epub 2013 Apr 11.
- Background: PubMed 20059383Yinghao S, Yang B, Gao X. The management of renal caliceal calculi with a newly designed ureteroscope: a rigid ureteroscope with a deflectable tip. J Endourol. 2010 Jan;24(1):23-6. doi: 10.1089/end.2009.0030.
- Background: PubMed 21109293Rebuck DA, Macejko A, Bhalani V, Ramos P, Nadler RB. The natural history of renal stone fragments following ureteroscopy. Urology. 2011 Mar;77(3):564-8. doi: 10.1016/j.urology.2010.06.056. Epub 2010 Dec 15.
- Background: PubMed 22982421Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.
- Background: PubMed 24035032Atis G, Arikan O, Gurbuz C, Yildirim A, Erol B, Pelit S, Ulus I, Caskurlu T. Comparison of different ureteroscope sizes in treating ureteral calculi in adult patients. Urology. 2013 Dec;82(6):1231-5. doi: 10.1016/j.urology.2013.07.021. Epub 2013 Sep 12.
- Background: PubMed 24507782Perez Castro E, Osther PJ, Jinga V, Razvi H, Stravodimos KG, Parikh K, Kural AR, de la Rosette JJ; CROES Ureteroscopy Global Study Group. Differences in ureteroscopic stone treatment and outcomes for distal, mid-, proximal, or multiple ureteral locations: the Clinical Research Office of the Endourological Society ureteroscopy global study. Eur Urol. 2014 Jul;66(1):102-9. doi: 10.1016/j.eururo.2014.01.011. Epub 2014 Jan 23.
- Background: PubMed 25361706Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72.
- Background: PubMed 21052986Wendt-Nordahl G, Mut T, Krombach P, Michel MS, Knoll T. Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors? Urol Res. 2011 Jun;39(3):185-8. doi: 10.1007/s00240-010-0331-0. Epub 2010 Nov 5.
- Background: PubMed 18186680Wendt-Nordahl G, Trojan L, Alken P, Michel MS, Knoll T. Ureteroscopy for stone treatment using new 270 degrees semiflexible endoscope: in vitro, ex vivo, and clinical application. J Endourol. 2007 Dec;21(12):1439-44. doi: 10.1089/end.2006.0291.
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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.
Yinghao Sun, MD study chair
Changhai Hospital
Guohua Zeng, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Hequn Chen, MD principal investigator
Xiangya Hospital of Central South University
Questions about this trial
What is this clinical trial studying?
A study testing the tip-flexible ureterorenoscope and the classic flexible ureteroscope in people with Renal Calculi, run by Ling Li, MD.
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 6 inclusion and 11 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 27 Apr 2015. 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?
Contact Ling Li, MD (086-18019766513, ejdll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone clearance (time frame: 12 weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02426931, which also lists 16 linked publications.
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 27 Apr 2015.