CholedocholithiasisNCT03536247
Papillary Balloon Dilation Versus Intraductal Lithotripsy
A study testing Initial therapy with papillary balloon dilation and Initial therapy with intraductal lithotripsy in people with Choledocholithiasis, run by University of Southern California at 2 sites in United States.
Trial summary
Our aim is to compare the efficacy, safety, procedural time required, and costs of a strategy initially employing cholangioscopy guided intraductal lithotripsy (laser/electrohydraulic lithtripsy (EHL)) versus a strategy initially using papillary dilation for removal of large bile duct stones. Read more about this study
- Who is it for?
- Ages 18 to 115 yearsHealthy volunteers can take part
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- Initial therapy with papillary balloon dilation and Initial therapy with intraductal lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Sep 2018to Dec 2024
- 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 115 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years and older
- Undergoing ERCP at LAC+Medical Center or Keck Hospital of USC for the standard indication of bile duct stones with evidence of a large stone (>1cm) demonstrated either on Ultrasound, computed tomography, prior ERCP, or magnetic resonance imaging.
Who cannot join
- Patients Under the age of 18
- Patients with biliary malignancy
- Prior biliary diversion surgery
- Prior gastric bypass surgery
- Patients who are incarcerated
- Patients who are unable to give consent
- Patients who pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Keck Hospital of USC
Los Angeles, California, 90033
Jeannette Delgado, 323-442-8462
- Recruiting
Los Angeles County + USC Medical Center
Los Angeles, California, 90033
James Buxbaum, MD, 323-409-1000 ext. 6939
About this study
Official title: Prospective Randomized Trial of Cholangioscopy Guided Intraductal Lithotripsy Versus Papillary Balloon Dilation for the Endoscopic Treatment of Large Bile Duct Stones
Our aim is to compare the efficacy, safety, procedural time required, and costs of a strategy initially employing cholangioscopy guided intraductal lithotripsy (laser/electrohydraulic lithtripsy (EHL)) versus a strategy initially using papillary dilation for removal of large bile duct stones.
Read the detailed description
The study will be a prospective single blind randomized comparative trial. All patients presenting with choledocholithiasis will be considered for the study. If their ultrasound, computed tomography, or magnetic resonance imaging demonstrates a large stone (>1cm) and they do not fulfill the exclusion criterion they will be eligible for the study. If a prior Endoscopic retrograde cholangiopancreatography (ERCP) demonstrates a stone >1cm, which could not be removed with standard methods, they will also be eligible. Randomization will be stratified based on whether or not the procedure is a first or repeat ERCP
Patients will be randomized using a computer generated randomization schedule with concealed allocation in a 1:1 assignment (allocation ratio) to initial cholangioscopy guided lithoripsy versus initial papillary dilation. Randomization will be blocked in groups of 12.
In those randomized to cholangioscopy-guided lithotripsy, the procedure will be performed in the standard manner using a single operator cholangioscopy system and a holmium laser or EHL (dependent on availability). Those in the papillary dilation arm will undergo the standard approach using the combined papillary dilation balloon sphincterotomy system. The patients will be blinded as to treatment arm.
"Conventional" methods including mechanical lithotripsy or stent placement may be used to remove stones/debris in combination with the specified intervention, as is done for standard clinical care. Use of these strategies will be recorded
If stone removal fails with the assigned strategy, this will be considered failure of the assigned intervention. This decision will be made by the attending endoscopist and recorded. The patient will then crossover into the other treatment arm.
The primary outcome will be complete stone clearance in the first study procedure by the assigned method. Additional outcomes will be total procedure time, cost of equipment, and number and type of complications. Additional ERCP may be needed for complete removal in some cases (i.e. complete removal in first attempt is not possible), thus we will also compare the number of ERCP needed for final stone clearance and whether stone removal is eventually achieved by endoscopic methods (comparison will be on an intention to treat basis). Additionally, if patients require surgical stone removal for the standard clinical indication in the case that endoscopic strategies are not successful, this will be recorded.
The patients will be followed clinically by the principal investigator assisted by a research coordinator on days 1,7 and 30 post procedures. This will be done as a brief follow up visit if the patient is still hospitalized or by telephone call thereafter.
Thus, all procedures performed in this study represent standard clinical care, which would be used even if the patients did not take part in the study, except that the initial choice to use cholangioscopy guided lithotripsy versus papillary dilation will be randomized.
- Conditions
- Choledocholithiasis
- Being tested
- Initial therapy with papillary balloon dilation, Initial therapy with intraductal lithotripsy
- Keywords
- bile duct stones, choledocholithiasis, ERCP, endoscopic retrograde cholangiopancreatograhy
- Medical subject headings
- Choledocholithiasis, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial therapy with papillary balloon dilationProcedure or surgery
Also called papillary dilation
patients will first undergo papillary dilation
Initial therapy with intraductal lithotripsyProcedure or surgery
patients will first undergo intraductal laser or electrohydraulic lithrotripsy
| Study group | Role | What they receive |
|---|---|---|
| Intraductal lithotripsy | Active comparator | Cholangioscopy enables therapeutic intervention including intracorporeal electro-hydraulic and laser lithotripsy for biliary stone disease with favorable efficacy and safety. Receives: Procedure: Initial therapy with intraductal lithotripsy |
| Papillary Balloon dilation | Active comparator | Balloon dilation of the Ampulla of Vater after a small sphincterotomy is an alternative technique that allows for removal of large bile duct stones in a safe and effective manner. Receives: Procedure: Initial therapy with papillary balloon dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First procedure stone clearance
Entire stone[s] removed in first procedure
Measured: 2 hours
Secondary outcomes (2)
Adverse Events
Pancreatitis, bleeding, perforation, infection
Measured: 1 week
Procedure Time
Length of procedure
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start7 Sep 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies 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
- Model description
- Patients will be randomized using a pre-generated randomization schedule with concealed allocation in a 1:1 assignment to initial cholangioscopy guided lithotrispy or papillary dilation. Randomization will be blocked in groups of 12.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ara Sahakian, University of Southern California
- Investigators
- Ara Sahakian, MD, Principal investigator, University of Southern CaliforniaJames Buxbaum, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536247
- Sponsor's protocol ID
- HS-17-00448
- Status last verified
- Jun 2022
- First submitted
- 14 May 2018
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang WH, Chu CH, Wang TE, Chen MJ, Lin CC. Outcome of simple use of mechanical lithotripsy of difficult common bile duct stones. World J Gastroenterol. 2005 Jan 28;11(4):593-6. doi: 10.3748/wjg.v11.i4.593.
PubMed 15641153Moon JH, Ko BM, Choi HJ, Hong SJ, Cheon YK, Cho YD, Lee JS, Lee MS, Shim CS. Intraductal balloon-guided direct peroral cholangioscopy with an ultraslim upper endoscope (with videos). Gastrointest Endosc. 2009 Aug;70(2):297-302. doi: 10.1016/j.gie.2008.11.019. Epub 2009 Apr 25.
PubMed 19394010Lee JG. Diagnosis and management of acute cholangitis. Nat Rev Gastroenterol Hepatol. 2009 Sep;6(9):533-41. doi: 10.1038/nrgastro.2009.126. Epub 2009 Aug 4.
PubMed 19652653Kim HI, Moon JH, Choi HJ, Lee JC, Ahn HS, Song AR, Lee TH, Cho YD, Park SH, Kim SJ. Holmium laser lithotripsy under direct peroral cholangioscopy by using an ultra-slim upper endoscope for patients with retained bile duct stones (with video). Gastrointest Endosc. 2011 Nov;74(5):1127-32. doi: 10.1016/j.gie.2011.07.027. Epub 2011 Sep 29.
PubMed 21963070Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
PubMed 21762903Stefanidis G, Viazis N, Pleskow D, Manolakopoulos S, Theocharis L, Christodoulou C, Kotsikoros N, Giannousis J, Sgouros S, Rodias M, Katsikani A, Chuttani R. Large balloon dilation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. Am J Gastroenterol. 2011 Feb;106(2):278-85. doi: 10.1038/ajg.2010.421. Epub 2010 Nov 2.
PubMed 21045816Itoi T, Itokawa F, Sofuni A, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Endoscopic sphincterotomy combined with large balloon dilation can reduce the procedure time and fluoroscopy time for removal of large bile duct stones. Am J Gastroenterol. 2009 Mar;104(3):560-5. doi: 10.1038/ajg.2008.67. Epub 2009 Jan 27.
PubMed 19174779Itoi T, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Umeda J, Moriyasu F. New large-diameter balloon-equipped sphincterotome for removal of large bile duct stones (with videos). Gastrointest Endosc. 2010 Oct;72(4):825-30. doi: 10.1016/j.gie.2010.06.018.
PubMed 20883862Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF, Dervenis C, Chan AC, Supe AN, Liau KH, Kim MH, Kim SW; Tokyo Guidelines Revision Committee. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24-34. doi: 10.1007/s00534-012-0561-3.
PubMed 23307001
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Cholangioscopy Guided Intraductal Lithotripsy Versus Papillary Balloon Dilation for the Endoscopic Treatment of Large Bile Duct Stones
- ClinicalTrials.gov ID
- NCT03536247
- Acronym / sponsor ID
- HS-17-00448
- Conditions
- Choledocholithiasis
- Keywords
- bile duct stones, choledocholithiasis, ERCP, endoscopic retrograde cholangiopancreatograhy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our aim is to compare the efficacy, safety, procedural time required, and costs of a strategy initially employing cholangioscopy guided intraductal lithotripsy (laser/electrohydraulic lithtripsy (EHL)) versus a strategy initially using papillary dilation for removal of large bile duct stones.
Detailed description
The study will be a prospective single blind randomized comparative trial. All patients presenting with choledocholithiasis will be considered for the study. If their ultrasound, computed tomography, or magnetic resonance imaging demonstrates a large stone (>1cm) and they do not fulfill the exclusion criterion they will be eligible for the study. If a prior Endoscopic retrograde cholangiopancreatography (ERCP) demonstrates a stone >1cm, which could not be removed with standard methods, they will also be eligible. Randomization will be stratified based on whether or not the procedure is a first or repeat ERCP
Patients will be randomized using a computer generated randomization schedule with concealed allocation in a 1:1 assignment (allocation ratio) to initial cholangioscopy guided lithoripsy versus initial papillary dilation. Randomization will be blocked in groups of 12.
In those randomized to cholangioscopy-guided lithotripsy, the procedure will be performed in the standard manner using a single operator cholangioscopy system and a holmium laser or EHL (dependent on availability). Those in the papillary dilation arm will undergo the standard approach using the combined papillary dilation balloon sphincterotomy system. The patients will be blinded as to treatment arm.
"Conventional" methods including mechanical lithotripsy or stent placement may be used to remove stones/debris in combination with the specified intervention, as is done for standard clinical care. Use of these strategies will be recorded
If stone removal fails with the assigned strategy, this will be considered failure of the assigned intervention. This decision will be made by the attending endoscopist and recorded. The patient will then crossover into the other treatment arm.
The primary outcome will be complete stone clearance in the first study procedure by the assigned method. Additional outcomes will be total procedure time, cost of equipment, and number and type of complications. Additional ERCP may be needed for complete removal in some cases (i.e. complete removal in first attempt is not possible), thus we will also compare the number of ERCP needed for final stone clearance and whether stone removal is eventually achieved by endoscopic methods (comparison will be on an intention to treat basis). Additionally, if patients require surgical stone removal for the standard clinical indication in the case that endoscopic strategies are not successful, this will be recorded.
The patients will be followed clinically by the principal investigator assisted by a research coordinator on days 1,7 and 30 post procedures. This will be done as a brief follow up visit if the patient is still hospitalized or by telephone call thereafter.
Thus, all procedures performed in this study represent standard clinical care, which would be used even if the patients did not take part in the study, except that the initial choice to use cholangioscopy guided lithotripsy versus papillary dilation will be randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized using a pre-generated randomization schedule with concealed allocation in a 1:1 assignment to initial cholangioscopy guided lithotrispy or papillary dilation. Randomization will be blocked in groups of 12.
| Arm | Type | Receives |
|---|---|---|
| Intraductal lithotripsy | Active comparator | Procedure: Initial therapy with intraductal lithotripsyCholangioscopy enables therapeutic intervention including intracorporeal electro-hydraulic and laser lithotripsy for biliary stone disease with favorable efficacy and safety. |
| Papillary Balloon dilation | Active comparator | Procedure: Initial therapy with papillary balloon dilationBalloon dilation of the Ampulla of Vater after a small sphincterotomy is an alternative technique that allows for removal of large bile duct stones in a safe and effective manner. |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years and older
- Undergoing ERCP at LAC+Medical Center or Keck Hospital of USC for the standard indication of bile duct stones with evidence of a large stone (>1cm) demonstrated either on Ultrasound, computed tomography, prior ERCP, or magnetic resonance imaging.
Key exclusion criteria (7 listed)
- Patients Under the age of 18
- Patients with biliary malignancy
- Prior biliary diversion surgery
- Prior gastric bypass surgery
- Patients who are incarcerated
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 |
|---|---|---|
| Initial therapy with papillary balloon dilationAlso: papillary dilationpatients will first undergo papillary dilation | Procedure or surgery | Papillary Balloon dilation |
| Initial therapy with intraductal lithotripsypatients will first undergo intraductal laser or electrohydraulic lithrotripsy | Procedure or surgery | Intraductal lithotripsy |
Primary outcome
First procedure stone clearance
Time frame: 2 hours
Entire stone[s] removed in first procedure
2 secondary outcomes
Adverse Events
Time frame: 1 week
Procedure Time
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Background: PubMed 15641153Chang WH, Chu CH, Wang TE, Chen MJ, Lin CC. Outcome of simple use of mechanical lithotripsy of difficult common bile duct stones. World J Gastroenterol. 2005 Jan 28;11(4):593-6. doi: 10.3748/wjg.v11.i4.593.
- Background: PubMed 19394010Moon JH, Ko BM, Choi HJ, Hong SJ, Cheon YK, Cho YD, Lee JS, Lee MS, Shim CS. Intraductal balloon-guided direct peroral cholangioscopy with an ultraslim upper endoscope (with videos). Gastrointest Endosc. 2009 Aug;70(2):297-302. doi: 10.1016/j.gie.2008.11.019. Epub 2009 Apr 25.
- Background: PubMed 19652653Lee JG. Diagnosis and management of acute cholangitis. Nat Rev Gastroenterol Hepatol. 2009 Sep;6(9):533-41. doi: 10.1038/nrgastro.2009.126. Epub 2009 Aug 4.
- Background: PubMed 21963070Kim HI, Moon JH, Choi HJ, Lee JC, Ahn HS, Song AR, Lee TH, Cho YD, Park SH, Kim SJ. Holmium laser lithotripsy under direct peroral cholangioscopy by using an ultra-slim upper endoscope for patients with retained bile duct stones (with video). Gastrointest Endosc. 2011 Nov;74(5):1127-32. doi: 10.1016/j.gie.2011.07.027. Epub 2011 Sep 29.
- Background: PubMed 21762903Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
- Background: PubMed 21045816Stefanidis G, Viazis N, Pleskow D, Manolakopoulos S, Theocharis L, Christodoulou C, Kotsikoros N, Giannousis J, Sgouros S, Rodias M, Katsikani A, Chuttani R. Large balloon dilation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. Am J Gastroenterol. 2011 Feb;106(2):278-85. doi: 10.1038/ajg.2010.421. Epub 2010 Nov 2.
- Background: PubMed 19174779Itoi T, Itokawa F, Sofuni A, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Endoscopic sphincterotomy combined with large balloon dilation can reduce the procedure time and fluoroscopy time for removal of large bile duct stones. Am J Gastroenterol. 2009 Mar;104(3):560-5. doi: 10.1038/ajg.2008.67. Epub 2009 Jan 27.
- Background: PubMed 20883862Itoi T, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Umeda J, Moriyasu F. New large-diameter balloon-equipped sphincterotome for removal of large bile duct stones (with videos). Gastrointest Endosc. 2010 Oct;72(4):825-30. doi: 10.1016/j.gie.2010.06.018.
- Background: PubMed 23307001Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF, Dervenis C, Chan AC, Supe AN, Liau KH, Kim MH, Kim SW; Tokyo Guidelines Revision Committee. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24-34. doi: 10.1007/s00534-012-0561-3.
- Individual participant dataSharing planned: No
Related trials for Choledocholithiasis
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
Recruiting
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
Cholelithiasis Associated With Common Bile Duct Stones
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.
Ara Sahakian, MD principal investigator
University of Southern California
James Buxbaum, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial therapy with papillary balloon dilation and Initial therapy with intraductal lithotripsy in people with Choledocholithiasis, run by University of Southern California at 2 sites 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 2 inclusion and 7 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Serna (323-409-6939, Jessica.Serna@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First procedure stone clearance (time frame: 2 hours). 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 NCT03536247, which also lists 9 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 15 Jun 2022.