Renal CalculiNCT01008267
Shockwave Lithotripsy (SWL) Under Selective, General Anesthesia.
An observational study of Renal Calculi and Ureteral Calculi, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
SWL is widely used in the treatment of patients with renal and ureteral calculi. Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi, Ureteral Calculi
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Oct 2010
- Phase
- Observational
- 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
Study population: Patients who failed in SWL process taken under sedation (standard protocol)
Who may be able to join
- Older than 18 years old
- Not pregnant
- All patients who failed in SWL process, taken under sedation (standard protocol)
Who cannot join
- Age < 18
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Anesthesiology department, Assaf-Harofeh MC
Beer-Yaakov, Zrifin, 70300
Zoya Haitov, MD, 089778080, ZoyaC@asaf.health.gov.il
Zoya Haitov, MD
About this study
Official title: Shockwave Lithotripsy (SWL) Under Regular General Anesthesia and Under General Anesthesia Using Bronchial Blocker.
SWL is widely used in the treatment of patients with renal and ureteral calculi. Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. Moreover, in some cases it is very difficult to focus on the stone because of its movement as a results of breathing. In order to prevent stone movement we want to use a bronchial blocker, processing a selective ventilation of the opposite side of stone location.
- Conditions
- Renal Calculi, Ureteral Calculi
- Medical subject headings
- Kidney Calculi, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SWL under general anesthesia | Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general anesthesia. | |
| SWL under general selective anesthesia | Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general selective anesthesia, using a bronchial blocker. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008267
- Sponsor's protocol ID
- 63/09
- Status last verified
- Mar 2009
- First submitted
- 4 Nov 2009
- Last updated
- 5 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Lithotripsy (SWL) Under Regular General Anesthesia and Under General Anesthesia Using Bronchial Blocker.
- ClinicalTrials.gov ID
- NCT01008267
- Acronym / sponsor ID
- 63/09
- Conditions
- Renal Calculi, Ureteral Calculi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (estimated)
- First posted
- 5 Nov 2009 (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.
SWL is widely used in the treatment of patients with renal and ureteral calculi. Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. Moreover, in some cases it is very difficult to focus on the stone because of its movement as a results of breathing. In order to prevent stone movement we want to use a bronchial blocker, processing a selective ventilation of the opposite side of stone location.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWL under general anesthesia | – | –Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general anesthesia. |
| SWL under general selective anesthesia | – | –Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general selective anesthesia, using a bronchial blocker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who failed in SWL process taken under sedation (standard protocol)
Key inclusion criteria (3 listed)
- Older than 18 years old
- Not pregnant
- All patients who failed in SWL process, taken under sedation (standard protocol)
Key exclusion criteria (2 listed)
- Age < 18
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
Anesthesiology department, Assaf-Harofeh MC
Beer-Yaakov, Zrifin, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Calculi and Ureteral Calculi, run by Assaf-Harofeh 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 3 inclusion and 2 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 5 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 5 Nov 2009.