Urinary StonesNCT00637650
Management of Fragments During Ureteroscopy
A study testing Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments and Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment in people with Urinary Stones, run by The Chaim Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Urinary Stones
- What is being tested?
- Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments and Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to May 2008
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with ureteral stones suitable for endoscopic treatment
Who cannot join
- presence of ipsilateral kidney stones
- known ureteral stricture
- previous placement of ureteral stent
- use of drugs with known activity on smooth ureteral muscle
- unwillingness or impossibility to return for follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.
The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.
- Conditions
- Urinary Stones
- Being tested
- Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments, Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragmentsProcedure or surgery
Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | Experimental group: patients in whom "stone dust" was left for spontaneous elimination Receives: Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment |
| A | Other | Control group: Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved Receives: Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments |
What is being measured
The primary outcome is the main question the study is designed to answer.
unplanned medical visits
Measured: 30 days
Secondary outcomes (1)
Hospital Admissions, need for pain killers, time to complete recovery
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary StonesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- The Chaim Sheba Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637650
- Sponsor's protocol ID
- 4638
- Status last verified
- Feb 2009
- First submitted
- 12 Mar 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00637650
- Acronym / sponsor ID
- 4638
- Conditions
- Urinary Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The Chaim Sheba Medical CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Mar 2008 (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.
The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragmentExperimental group: patients in whom "stone dust" was left for spontaneous elimination |
| A | Other | Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragmentsControl group: Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with ureteral stones suitable for endoscopic treatment
Key exclusion criteria (5 listed)
- presence of ipsilateral kidney stones
- known ureteral stricture
- previous placement of ureteral stent
- use of drugs with known activity on smooth ureteral muscle
- unwillingness or impossibility to return for follow-up
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 |
|---|---|---|
| Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments | Procedure or surgery | A |
| Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment | Procedure or surgery | B |
Primary outcome
unplanned medical visits
Time frame: 30 days
1 secondary outcome
Hospital Admissions, need for pain killers, time to complete recovery
Time frame: 60 days
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 10 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments and Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment in people with Urinary Stones, run by The Chaim Sheba Medical Center at 1 site in Israel.
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 1 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 10 Feb 2009. 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 Israel. 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?
unplanned medical visits (time frame: 30 days). 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 10 Feb 2009.