Kidney CalculiNCT03959683
ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
A study testing Trilogy Lithotrite and The ShockPulse-SE Lithotripsy System in people with Kidney Calculi, run by Indiana University at 4 sites in 2 countries.
Trial summary
The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Trilogy Lithotrite and The ShockPulse-SE Lithotripsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 Feb 2019to 18 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- At least one renal stone > 1.5 cm in maximum diameter as measured on preoperative CT scan
- Patient is scheduled to undergo a percutaneous nephrolithotomy procedure
- Willing and able to provide informed consent
Who cannot join
- Pregnant
- Active urinary tract infection
- Prior shock wave lithotripsy within 3 months of study procedure
- Multiple percutaneous access sites are anticipated
- Unable or unwilling to provide informed consent -
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
The Ohio State University
Columbus, Ohio, 43212
Indiana University Health Physicians Urology
Indianapolis, Indiana, 46202
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Canada1 site
The University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Prospective Randomized Multicenter Trial Comparing Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. We hypothesize that the Trilogy will increase the stone clearance rate by 25% compared to the Shockpulse-SE
Read the detailed description
Large and complex renal calculi, defined as those with a maximum diameter of ≥ 1.5 cm, can be removed from the upper urinary tract by percutaneous nephrolithotomy but the stones usually require fragmentation in order to remove them through the access site. There are a number of commercially available intracorporeal lithotripters used to fragment or break kidney stones to allow elimination including pneumatic, ultrasonic, and combination devices. Each technology has its own relative advantages and disadvantages.
New versions of intracorporeal lithotripter devices have been introduced with improvements meant to address prior functional limitations such as probe clogging or breaking and cumbersome hand piece design.
The Trilogy lithotrite is the newest generation device stone fragmentation device from Boston Scientific. The Trilogy device uses unique technology to efficiently fragment and remove stone material, superior to other devices on the market based on preliminary bench testing. From Olympus, the ShockPulse-SE Lithotripsy System (Cybersonics, Erie, PA, USA) is a constant ultrasonic wave energy lithotripter with intermittent shock wave (ballistic/mechanical) energy. The ShockPulse-SE has a single probe design with an OD of 3.76 mm which allows for larger sized stone fragments to be vacuumed from the urothelium. The larger, single lumen also allows for a high flow rate to reduce probe clogging events. The end result is faster stone clearance rates based on in vitro studies.
The objective of this study is to compare the performance, as measured by the stone clearance rate at time of percutaneous nephrolithotomy, of the ShockPulse-SE Lithotripsy System to the Trilogy lithotrite when used for large complex renal calculi.
The Trilogy has been FDA cleared for fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Trilogy is a combined piezoelectric/pneumatic device capable of fragmenting calculi and aspirating stone debris. The novel technology in Trilogy has been demonstrated in bench testing to more quickly disintegrate stones compared to other devices.
The ShockPulse-SE Lithotripsy System has been FDA cleared fragmentation of urinary tract calculi in the kidney, ureter, and bladder. The ShockPulse-SE System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy which quickly disintegrates stones.
Study Objectives To compare the performance, as measured by the stone clearance rate at time of percutaneous nephrolithotomy, of the ShockPulse-SE Lithotripsy System to the Trilogy Lithotrite.
Study Endpoints Primary Endpoint Stone clearance rate defined as the kidney stone surface area measured by preoperative computed tomography (CT) scan divided by the time to remove the targeted stone burden.
Time to remove the targeted stone burden is measured at time the lithotripter unit starts fragmenting the stone to time all fragments are removed from the kidney based on visual inspection. This is prior to final visual inspection of the kidney with a flexible nephroscope.
Additional Endpoints
- Device malfunctions
- All complications measured by the Clavien Classification of Surgical Complications Stone free status as defined by the presence or absence of stone material on postoperative day 1 CT imaging This study is a post-market, prospective, randomized, multicenter, 2-arm, comparative trial.
Scale and Duration A total of 100 participants will be enrolled and treated at 4 study sites (3 USA, 1 Canada). Two sites will enroll 16 participants and 2 will enroll at least 18 participants. Each subject will be followed for approximately 6-12 weeks after the study procedure. It is anticipated for the entire study to last approximately 12 months.
Treatment Assignment The participants will be block randomized 1:1 to either stone removal with the Trilogy or the ShockPulse-SE device. All randomization will occur at the central study site via computer randomization by the statistician to limit selection bias.
Justification for the Study Design This study will compare performance of two devices for the treatment of large renal calculi. The study has been designed as a prospective, multi-centric, randomized, comparative study. The intent of this design is to minimize bias and to allow for statistical comparison of the two treatment groups.
Point of Enrollment A participant will be considered enrolled in the study if they meet all eligibility criteria and after the participant signs and dates the informed consent form (ICF). No study-related procedures can take placed until the ICF is signed.
Withdrawal All participants enrolled in the clinical study (including those withdrawn from the clinical study or lost to follow-up) shall be accounted for and documented. If a participant withdraws from the clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems related to study device safety or performance, the investigator shall ask for the participant's permission to follow his/her status/condition outside of the clinical study.
Reasons for withdrawal include:
- Physician discretion
- Participant choice to withdraw consent
- Lost to follow-up
- If the participant dies due to any cause
While study withdrawal is discouraged, participants may withdraw from the study at any time, with or without reason, and without prejudice to further treatment.
If any treated study patient is unable to return to the study center after treatment, efforts will be made to obtain complete follow-up information from the patient's primary physician. The reason for a patient's failure to return for the necessary follow-up visits or for a patient's discontinuance from the study must be determined and recorded in the case report forms (CRF).
All applicable CRFs up to the point of participant withdrawal must be completed. Participants who are "lost to follow up" should have documented attempts to contact them.
Additional data may no longer be collected after the point at which a participant has been withdrawn from the study or withdraws his/her consent, for whatever reason. Data collected up to the point of participant withdrawal may be used for study analysis.
Informed Consent All participants taking part in this clinical study must undergo the informed consent process. Participants must be allowed adequate time to review the consent, raise questions, and make a voluntary decision to participate in the clinical study. Each participant must sign and date the IRB approved informed consent form before any clinical study-related procedures are performed. A copy of signed informed consent form will be provided to the participant for his/her records. A participant's participation in the clinical study begins with the signing and dating of the informed consent form.
- Conditions
- Kidney Calculi
- Being tested
- Trilogy Lithotrite, The ShockPulse-SE Lithotripsy System
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trilogy LithotriteDevice
The Trilogy has been FDA cleared for fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Trilogy is a combined piezoelectric/pneumatic device capable of fragmenting calculi and aspirating stone debris. The novel technology in Trilogy has been demonstrated in bench testing to more quickly disintegrate stones compared to other devices.
The ShockPulse-SE Lithotripsy SystemDevice
The ShockPulse-SE System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy which quickly disintegrates stones.
| Study group | Role | What they receive |
|---|---|---|
| Trilogy device | Active comparator | Trilogy Lithotrite to fragment urinary tract calculi in the kidney, ureter and bladder Receives: Device: Trilogy Lithotrite |
| ShockPulse-SE | Active comparator | ShockPulse-SE Lithotripsy System to fragment urinary calculi in the kidney, ureter and bladder Receives: Device: The ShockPulse-SE Lithotripsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Clearance Rate Defined as the Kidney Stone Surface Area Measured by Pre-operative Computed Tomography (CT) Scan Divided by the Time to Remove the Targeted Stone Burden.
Time to remove the targeted stone burden is measured at time the lithotripter unit starts fragmenting the stone to time all fragments are removed from the kidney based on visual inspection. This is prior to final visual inspection of the kidney with a flexible nephroscope.
Measured: Postoperative day 1
Secondary outcomes (3)
Device Malfunctions During Intraoperative Device Use as Described by Surgeon Completing the Device Questionnaire.
any malfunctions during intraoperative device use
Measured: any malfunctions during intraoperative device use
All Complications Measured by the Clavien Classification of Surgical Complications
Clavien Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Acceptable therapeutic regiments are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside.
Clavien Grade II: Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Clavien Grade III: Requiring surgical, endoscopic or radiological intervention
Measured: 90 days
Number of Participants With Stone Free Status as Defined by the Presence or Absence of Stone Material on Postoperative CT Imaging and at Final Follow up
Stone free status must be assessed postoperative day 1 by CT scan.
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start19 Feb 2019
- Primary completion29 Jul 2020
- Study completion18 Nov 2020
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 (1)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 Indiana 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, multicenter, 2 arm, comparative trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Ohio State University, Mayo Clinic, University of British Columbia
- Responsible party
- Principal investigator, Tim Large, Indiana University
- Investigators
- Amy E Krambeck, MD, Principal investigator, Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959683
- Sponsor's protocol ID
- 1803658961
- Status last verified
- Mar 2023
- First submitted
- 16 May 2019
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Large T, Nottingham C, Brinkman E, Agarwal D, Ferrero A, Sourial M, Stern K, Rivera M, Knudsen B, Humphreys M, Krambeck A. Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial. J Endourol. 2021 Sep;35(9):1326-1332. doi: 10.1089/end.2020.1097. Epub 2021 Aug 16.
PubMed 33843245
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Trial Comparing Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
- ClinicalTrials.gov ID
- NCT03959683
- Acronym / sponsor ID
- 1803658961
- Conditions
- Kidney Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Ohio State University, Mayo Clinic, University of British Columbia
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. We hypothesize that the Trilogy will increase the stone clearance rate by 25% compared to the Shockpulse-SE
Detailed description
Large and complex renal calculi, defined as those with a maximum diameter of ≥ 1.5 cm, can be removed from the upper urinary tract by percutaneous nephrolithotomy but the stones usually require fragmentation in order to remove them through the access site. There are a number of commercially available intracorporeal lithotripters used to fragment or break kidney stones to allow elimination including pneumatic, ultrasonic, and combination devices. Each technology has its own relative advantages and disadvantages.
New versions of intracorporeal lithotripter devices have been introduced with improvements meant to address prior functional limitations such as probe clogging or breaking and cumbersome hand piece design.
The Trilogy lithotrite is the newest generation device stone fragmentation device from Boston Scientific. The Trilogy device uses unique technology to efficiently fragment and remove stone material, superior to other devices on the market based on preliminary bench testing. From Olympus, the ShockPulse-SE Lithotripsy System (Cybersonics, Erie, PA, USA) is a constant ultrasonic wave energy lithotripter with intermittent shock wave (ballistic/mechanical) energy. The ShockPulse-SE has a single probe design with an OD of 3.76 mm which allows for larger sized stone fragments to be vacuumed from the urothelium. The larger, single lumen also allows for a high flow rate to reduce probe clogging events. The end result is faster stone clearance rates based on in vitro studies.
The objective of this study is to compare the performance, as measured by the stone clearance rate at time of percutaneous nephrolithotomy, of the ShockPulse-SE Lithotripsy System to the Trilogy lithotrite when used for large complex renal calculi.
The Trilogy has been FDA cleared for fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Trilogy is a combined piezoelectric/pneumatic device capable of fragmenting calculi and aspirating stone debris. The novel technology in Trilogy has been demonstrated in bench testing to more quickly disintegrate stones compared to other devices.
The ShockPulse-SE Lithotripsy System has been FDA cleared fragmentation of urinary tract calculi in the kidney, ureter, and bladder. The ShockPulse-SE System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy which quickly disintegrates stones.
Study Objectives To compare the performance, as measured by the stone clearance rate at time of percutaneous nephrolithotomy, of the ShockPulse-SE Lithotripsy System to the Trilogy Lithotrite.
Study Endpoints Primary Endpoint Stone clearance rate defined as the kidney stone surface area measured by preoperative computed tomography (CT) scan divided by the time to remove the targeted stone burden.
Time to remove the targeted stone burden is measured at time the lithotripter unit starts fragmenting the stone to time all fragments are removed from the kidney based on visual inspection. This is prior to final visual inspection of the kidney with a flexible nephroscope.
Additional Endpoints
- Device malfunctions
- All complications measured by the Clavien Classification of Surgical Complications Stone free status as defined by the presence or absence of stone material on postoperative day 1 CT imaging This study is a post-market, prospective, randomized, multicenter, 2-arm, comparative trial.
Scale and Duration A total of 100 participants will be enrolled and treated at 4 study sites (3 USA, 1 Canada). Two sites will enroll 16 participants and 2 will enroll at least 18 participants. Each subject will be followed for approximately 6-12 weeks after the study procedure. It is anticipated for the entire study to last approximately 12 months.
Treatment Assignment The participants will be block randomized 1:1 to either stone removal with the Trilogy or the ShockPulse-SE device. All randomization will occur at the central study site via computer randomization by the statistician to limit selection bias.
Justification for the Study Design This study will compare performance of two devices for the treatment of large renal calculi. The study has been designed as a prospective, multi-centric, randomized, comparative study. The intent of this design is to minimize bias and to allow for statistical comparison of the two treatment groups.
Point of Enrollment A participant will be considered enrolled in the study if they meet all eligibility criteria and after the participant signs and dates the informed consent form (ICF). No study-related procedures can take placed until the ICF is signed.
Withdrawal All participants enrolled in the clinical study (including those withdrawn from the clinical study or lost to follow-up) shall be accounted for and documented. If a participant withdraws from the clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems related to study device safety or performance, the investigator shall ask for the participant's permission to follow his/her status/condition outside of the clinical study.
Reasons for withdrawal include:
- Physician discretion
- Participant choice to withdraw consent
- Lost to follow-up
- If the participant dies due to any cause
While study withdrawal is discouraged, participants may withdraw from the study at any time, with or without reason, and without prejudice to further treatment.
If any treated study patient is unable to return to the study center after treatment, efforts will be made to obtain complete follow-up information from the patient's primary physician. The reason for a patient's failure to return for the necessary follow-up visits or for a patient's discontinuance from the study must be determined and recorded in the case report forms (CRF).
All applicable CRFs up to the point of participant withdrawal must be completed. Participants who are "lost to follow up" should have documented attempts to contact them.
Additional data may no longer be collected after the point at which a participant has been withdrawn from the study or withdraws his/her consent, for whatever reason. Data collected up to the point of participant withdrawal may be used for study analysis.
Informed Consent All participants taking part in this clinical study must undergo the informed consent process. Participants must be allowed adequate time to review the consent, raise questions, and make a voluntary decision to participate in the clinical study. Each participant must sign and date the IRB approved informed consent form before any clinical study-related procedures are performed. A copy of signed informed consent form will be provided to the participant for his/her records. A participant's participation in the clinical study begins with the signing and dating of the informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, multicenter, 2 arm, comparative trial
| Arm | Type | Receives |
|---|---|---|
| Trilogy device | Active comparator | Device: Trilogy LithotriteTrilogy Lithotrite to fragment urinary tract calculi in the kidney, ureter and bladder |
| ShockPulse-SE | Active comparator | Device: The ShockPulse-SE Lithotripsy SystemShockPulse-SE Lithotripsy System to fragment urinary calculi in the kidney, ureter and bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- At least one renal stone > 1.5 cm in maximum diameter as measured on preoperative CT scan
- Patient is scheduled to undergo a percutaneous nephrolithotomy procedure
- Willing and able to provide informed consent
Key exclusion criteria (5 listed)
- Pregnant
- Active urinary tract infection
- Prior shock wave lithotripsy within 3 months of study procedure
- Multiple percutaneous access sites are anticipated
- Unable or unwilling to provide informed consent -
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 |
|---|---|---|
| Trilogy LithotriteThe Trilogy has been FDA cleared for fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Trilogy is a combined piezoelectric/pneumatic device capable of fragmenting calculi and aspirating stone debris. The novel technology in Trilogy has been demonstrated in bench testing to more quickly disintegrate stones compared to other devices. | Device | Trilogy device |
| The ShockPulse-SE Lithotripsy SystemThe ShockPulse-SE System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy which quickly disintegrates stones. | Device | ShockPulse-SE |
Primary outcome
Stone Clearance Rate Defined as the Kidney Stone Surface Area Measured by Pre-operative Computed Tomography (CT) Scan Divided by the Time to Remove the Targeted Stone Burden.
Time frame: Postoperative day 1
Time to remove the targeted stone burden is measured at time the lithotripter unit starts fragmenting the stone to time all fragments are removed from the kidney based on visual inspection. This is prior to final visual inspection of the kidney with a flexible nephroscope.
3 secondary outcomes
Device Malfunctions During Intraoperative Device Use as Described by Surgeon Completing the Device Questionnaire.
Time frame: any malfunctions during intraoperative device use
All Complications Measured by the Clavien Classification of Surgical Complications
Time frame: 90 days
Number of Participants With Stone Free Status as Defined by the Presence or Absence of Stone Material on Postoperative CT Imaging and at Final Follow up
Time frame: postoperative day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33843245Large T, Nottingham C, Brinkman E, Agarwal D, Ferrero A, Sourial M, Stern K, Rivera M, Knudsen B, Humphreys M, Krambeck A. Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial. J Endourol. 2021 Sep;35(9):1326-1332. doi: 10.1089/end.2020.1097. Epub 2021 Aug 16.
- 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.
Amy E Krambeck, MD principal investigator
Indiana University Health
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trilogy Lithotrite and The ShockPulse-SE Lithotripsy System in people with Kidney Calculi, run by Indiana University at 4 sites in 2 countries.
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 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 12 Apr 2023). 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?
Stone Clearance Rate Defined as the Kidney Stone Surface Area Measured by Pre-operative Computed Tomography (CT) Scan Divided by the Time to Remove the Targeted Stone Burden. (time frame: Postoperative day 1). 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 NCT03959683, which also lists 1 linked publication.
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 2023.