Gall StonesEHLvlaserNCT01571271
Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
A study testing Laser Lithotripsy and Electrohydraulic Lithotripsy in people with Gall Stones, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gall Stones
- What is being tested?
- Laser Lithotripsy and Electrohydraulic Lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
- Adults able to provide informed consent
Who cannot join
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.
Read the detailed description
Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.
- Conditions
- Gall Stones
- Being tested
- Laser Lithotripsy, Electrohydraulic Lithotripsy
- Keywords
- biliary, lithotripsy, gall stones, bile duct, Biliary stones
- Medical subject headings
- Gallstones, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser LithotripsyProcedure or surgery
Also called Lithotripsy
Laser Lithotripsy
Electrohydraulic LithotripsyProcedure or surgery
Electrohydraulic Lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Electrohydraulic lithotripsy | Experimental | Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method Receives: Procedure: Electrohydraulic Lithotripsy |
| Laser Lithotripsy | Experimental | Laser Lithotripsy: Lithotripsy will be performed using laser method Receives: Procedure: Laser Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Identify which technique takes less time to completion.
Measured: Procudre duration
Secondary outcomes (1)
Number of shocks
Comparsion between procudures of the number of shocks to fragment stones
Measured: Procedure duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall StonesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansour Parsi, MD, The Cleveland Clinic
- Investigators
- Mansour A. Parsi, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571271
- Sponsor's protocol ID
- 09-168
- Acronym
- EHLvlaser
- Status last verified
- Mar 2017
- First submitted
- 23 Dec 2009
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
- ClinicalTrials.gov ID
- NCT01571271
- Acronym / sponsor ID
- EHLvlaser / 09-168
- Conditions
- Gall Stones
- Keywords
- biliary, lithotripsy, gall stones, bile duct, Biliary stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Apr 2012 (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.
Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.
Detailed description
Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrohydraulic lithotripsy | Experimental | Procedure: Electrohydraulic LithotripsyElectrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method |
| Laser Lithotripsy | Experimental | Procedure: Laser LithotripsyLaser Lithotripsy: Lithotripsy will be performed using laser method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
- Adults able to provide informed consent
Key exclusion criteria (1 listed)
- Pregnancy or lactation
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 |
|---|---|---|
| Laser LithotripsyAlso: LithotripsyLaser Lithotripsy | Procedure or surgery | Laser Lithotripsy |
| Electrohydraulic LithotripsyElectrohydraulic Lithotripsy | Procedure or surgery | Electrohydraulic lithotripsy |
Primary outcome
Time
Time frame: Procudre duration
Identify which technique takes less time to completion.
1 secondary outcome
Number of shocks
Time frame: Procedure duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- 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.
Mansour A. Parsi, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Lithotripsy and Electrohydraulic Lithotripsy in people with Gall Stones, run by The Cleveland Clinic 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 2 inclusion and 1 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 30 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time (time frame: Procudre duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.