Kidney CalculiNCT03040466
Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope
A study testing reusable fiberoptic ureteroscope and disposable digital ureteroscope in people with Kidney Calculi and Ureter Calculi, run by University of California, San Francisco at 1 site in United States.
Trial summary
Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Calculi, Ureter Calculi
- What is being tested?
- reusable fiberoptic ureteroscope and disposable digital ureteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age at their first clinical visit.
- Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging
- Patients being able and willing to provide consent.
Who cannot join
- Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
- Pregnancy.
- Staged ureteroscopic procedure.
- Antegrade flexible ureteroscopy.
- Dual procedures (ureteroscopy concurrently performed with other operations).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone
Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital.
Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.
Read the detailed description
This is a single center, prospective, randomized controlled pragmatic clinical trial designed to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or ureteral stones are planned to recruit for the study. All subjects will be computer sequence-randomized into having their ureteroscopic treatment performed with a disposable (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible ureteroscope. Patient's demographics, physical, laboratory, and image findings will be collected before surgery. These clinical data are already being collected as part of an ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue and need for a second ureteroscope during the case will be recorded during the treatment course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The following surgical treatment will be used similarly for all three randomized arms and represents standard of case therapy:
Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a holmium YAG laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved.
After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the end of the procedure to drain the kidney for 2-21 days if it is clinically indicated.
The total duration of the study is expected to be one year for subject recruitment and one year and six months for final subject follow-up.
- Conditions
- Kidney Calculi, Ureter Calculi
- Being tested
- reusable fiberoptic ureteroscope, disposable digital ureteroscope
- Keywords
- ureteroscopy, flexible ureteroscope, randomized controlled trial
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reusable fiberoptic ureteroscopeDevice
We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
disposable digital ureteroscopeDevice
We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
| Study group | Role | What they receive |
|---|---|---|
| reusable fiberoptic ureteroscope | Active comparator | For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. Receives: Device: reusable fiberoptic ureteroscope |
| disposable digital ureteroscope | Experimental | For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. Receives: Device: disposable digital ureteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Procedure Time
Measured: at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes
Secondary outcomes (2)
Number of Participants That Are Stone Free
this will be determined by either CT, US, or KUB
Measured: three month after surgery
Number of Participants With Complications
Measured: from during the surgery to three months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startAug 2014
- Primary completionSep 2016
- Study completionSep 2016
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.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Chi, MD, Principal investigator, Urology, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040466
- Sponsor's protocol ID
- 16-20844
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2017
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Healy KA, Pak RW, Cleary RC, Colon-Herdman A, Bagley DH. Hand problems among endourologists. J Endourol. 2011 Dec;25(12):1915-20. doi: 10.1089/end.2011.0128. Epub 2011 Oct 17.
PubMed 22004843Karaolides T, Bach C, Kachrilas S, Goyal A, Masood J, Buchholz N. Improving the durability of digital flexible ureteroscopes. Urology. 2013 Apr;81(4):717-22. doi: 10.1016/j.urology.2013.01.016. Epub 2013 Mar 7.
PubMed 23465156Multescu R, Geavlete B, Geavlete P. A new era: performance and limitations of the latest models of flexible ureteroscopes. Urology. 2013 Dec;82(6):1236-9. doi: 10.1016/j.urology.2013.07.022. Epub 2013 Aug 28.
PubMed 23992972Somani 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 24001703Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible ureteroscope durability seen in a large public tertiary care center with multiple surgeons. Urology. 2014 Jul;84(1):42-5. doi: 10.1016/j.urology.2014.01.022. Epub 2014 May 14.
PubMed 24837456de 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 24890883Tosoian JJ, Ludwig W, Sopko N, Mullins JK, Matlaga BR. The effect of repair costs on the profitability of a ureteroscopy program. J Endourol. 2015 Apr;29(4):406-9. doi: 10.1089/end.2014.0435. Epub 2014 Nov 7.
PubMed 25286008Buttice S, Sener TE, Netsch C, Emiliani E, Pappalardo R, Magno C. LithoVue: A new single-use digital flexible ureteroscope. Cent European J Urol. 2016;69(3):302-305. doi: 10.5173/ceju.2016.872. Epub 2016 Aug 26. No abstract available.
PubMed 27730000Doizi S, Kamphuis G, Giusti G, Andreassen KH, Knoll T, Osther PJ, Scoffone C, Perez-Fentes D, Proietti S, Wiseman O, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue): a European prospective multicentric feasibility study. World J Urol. 2017 May;35(5):809-818. doi: 10.1007/s00345-016-1936-x. Epub 2016 Sep 26.
PubMed 27671898Martin CJ, McAdams SB, Abdul-Muhsin H, Lim VM, Nunez-Nateras R, Tyson MD, Humphreys MR. The Economic Implications of a Reusable Flexible Digital Ureteroscope: A Cost-Benefit Analysis. J Urol. 2017 Mar;197(3 Pt 1):730-735. doi: 10.1016/j.juro.2016.09.085. Epub 2016 Sep 28.
PubMed 27693449Usawachintachit M, Isaacson DS, Taguchi K, Tzou DT, Hsi RS, Sherer BA, Stoller ML, Chi T. A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. J Endourol. 2017 May;31(5):468-475. doi: 10.1089/end.2017.0027. Epub 2017 Mar 13.
PubMed 28287823
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone
- ClinicalTrials.gov ID
- NCT03040466
- Acronym / sponsor ID
- 16-20844
- Conditions
- Kidney Calculi, Ureter Calculi
- Keywords
- ureteroscopy, flexible ureteroscope, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital.
Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.
Detailed description
This is a single center, prospective, randomized controlled pragmatic clinical trial designed to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or ureteral stones are planned to recruit for the study. All subjects will be computer sequence-randomized into having their ureteroscopic treatment performed with a disposable (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible ureteroscope. Patient's demographics, physical, laboratory, and image findings will be collected before surgery. These clinical data are already being collected as part of an ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue and need for a second ureteroscope during the case will be recorded during the treatment course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The following surgical treatment will be used similarly for all three randomized arms and represents standard of case therapy:
Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a holmium YAG laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved.
After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the end of the procedure to drain the kidney for 2-21 days if it is clinically indicated.
The total duration of the study is expected to be one year for subject recruitment and one year and six months for final subject follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.
| Arm | Type | Receives |
|---|---|---|
| reusable fiberoptic ureteroscope | Active comparator | Device: reusable fiberoptic ureteroscopeFor this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. |
| disposable digital ureteroscope | Experimental | Device: disposable digital ureteroscopeFor this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥ 18 years of age at their first clinical visit.
- Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging
- Patients being able and willing to provide consent.
Key exclusion criteria (5 listed)
- Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
- Pregnancy.
- Staged ureteroscopic procedure.
- Antegrade flexible ureteroscopy.
- Dual procedures (ureteroscopy concurrently performed with other operations).
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 |
|---|---|---|
| reusable fiberoptic ureteroscopeWe will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones. | Device | reusable fiberoptic ureteroscope |
| disposable digital ureteroscopeWe will use disposable digital ureteroscopes for the treatment of kidney and ureter stones. | Device | disposable digital ureteroscope |
Primary outcome
Overall Procedure Time
Time frame: at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes
2 secondary outcomes
Number of Participants That Are Stone Free
Time frame: three month after surgery
Number of Participants With Complications
Time frame: from during the surgery to three months after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22004843Healy KA, Pak RW, Cleary RC, Colon-Herdman A, Bagley DH. Hand problems among endourologists. J Endourol. 2011 Dec;25(12):1915-20. doi: 10.1089/end.2011.0128. Epub 2011 Oct 17.
- Background: PubMed 23465156Karaolides T, Bach C, Kachrilas S, Goyal A, Masood J, Buchholz N. Improving the durability of digital flexible ureteroscopes. Urology. 2013 Apr;81(4):717-22. doi: 10.1016/j.urology.2013.01.016. Epub 2013 Mar 7.
- Background: PubMed 23992972Multescu R, Geavlete B, Geavlete P. A new era: performance and limitations of the latest models of flexible ureteroscopes. Urology. 2013 Dec;82(6):1236-9. doi: 10.1016/j.urology.2013.07.022. Epub 2013 Aug 28.
- Background: PubMed 24001703Somani 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.
- Background: PubMed 24837456Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible ureteroscope durability seen in a large public tertiary care center with multiple surgeons. Urology. 2014 Jul;84(1):42-5. doi: 10.1016/j.urology.2014.01.022. Epub 2014 May 14.
- 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 25286008Tosoian JJ, Ludwig W, Sopko N, Mullins JK, Matlaga BR. The effect of repair costs on the profitability of a ureteroscopy program. J Endourol. 2015 Apr;29(4):406-9. doi: 10.1089/end.2014.0435. Epub 2014 Nov 7.
- Background: PubMed 27730000Buttice S, Sener TE, Netsch C, Emiliani E, Pappalardo R, Magno C. LithoVue: A new single-use digital flexible ureteroscope. Cent European J Urol. 2016;69(3):302-305. doi: 10.5173/ceju.2016.872. Epub 2016 Aug 26. No abstract available.
- Background: PubMed 27671898Doizi S, Kamphuis G, Giusti G, Andreassen KH, Knoll T, Osther PJ, Scoffone C, Perez-Fentes D, Proietti S, Wiseman O, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue): a European prospective multicentric feasibility study. World J Urol. 2017 May;35(5):809-818. doi: 10.1007/s00345-016-1936-x. Epub 2016 Sep 26.
- Background: PubMed 27693449Martin CJ, McAdams SB, Abdul-Muhsin H, Lim VM, Nunez-Nateras R, Tyson MD, Humphreys MR. The Economic Implications of a Reusable Flexible Digital Ureteroscope: A Cost-Benefit Analysis. J Urol. 2017 Mar;197(3 Pt 1):730-735. doi: 10.1016/j.juro.2016.09.085. Epub 2016 Sep 28.
- Results publication: PubMed 28287823Usawachintachit M, Isaacson DS, Taguchi K, Tzou DT, Hsi RS, Sherer BA, Stoller ML, Chi T. A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. J Endourol. 2017 May;31(5):468-475. doi: 10.1089/end.2017.0027. Epub 2017 Mar 13.
- Individual participant dataSharing planned: No
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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.
Thomas Chi, MD principal investigator
Urology, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reusable fiberoptic ureteroscope and disposable digital ureteroscope in people with Kidney Calculi and Ureter Calculi, run by University of California, San Francisco 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 5 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 1 Oct 2020. 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 1 Oct 2020). 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?
Overall Procedure Time (time frame: at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes). 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 NCT03040466, which also lists 12 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 1 Oct 2020.