Upper Tract UreterolithiasisPhase 2NCT00478998
Comparing Patients After ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
A Phase 2 study testing Tamsulosin in people with Upper Tract Ureterolithiasis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Tract Ureterolithiasis
- What is being tested?
- Tamsulosin
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients above 18 yrs of age.
- Single urolithiasis up to 2 cm.
- Kidney/ureters that haven't undergone previous ESWL or stent insertion.
- Normal renal function (creatinine below 100mmo1/1).
- Sterile urine culture.
- Normal CBC, blood electrolytes and coagulation studies.
- Radioopaque stones.
Who cannot join
- More than one stone per kidney unit.
- Patients receiving steroids, NSAIDS, calcium channel blockers or alpha blockers on a regular basis.
- Anatomical anomalies or uromechanical obstruction.
- Single kidney.
- Cystinuria.
- Soldiers or pregnant women.
- Patients under 18 year
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91120
Mordechai Duvdevani, MD, 0508946816, moti_duv@yahoo.com
Mordechai Duvdevani, MD
About this study
Official title: Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents .
- Conditions
- Upper Tract Ureterolithiasis
- Being tested
- Tamsulosin
- Keywords
- expulsion therapy, tamsulosin, ureterolithiasis, stents
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
stone status at 3 month .
stone free
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract UreterolithiasisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Mordechai Duvdevani, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478998
- Sponsor's protocol ID
- 890pal- HMO-CTIL
- Status last verified
- May 2007
- First submitted
- 24 May 2007
- Last updated
- 25 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
- ClinicalTrials.gov ID
- NCT00478998
- Acronym / sponsor ID
- 890pal- HMO-CTIL
- Conditions
- Upper Tract Ureterolithiasis
- Keywords
- expulsion therapy, tamsulosin, ureterolithiasis, stents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 25 May 2007 (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 see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients above 18 yrs of age.
- Single urolithiasis up to 2 cm.
- Kidney/ureters that haven't undergone previous ESWL or stent insertion.
- Normal renal function (creatinine below 100mmo1/1).
- Sterile urine culture.
Key exclusion criteria (7 listed)
- More than one stone per kidney unit.
- Patients receiving steroids, NSAIDS, calcium channel blockers or alpha blockers on a regular basis.
- Anatomical anomalies or uromechanical obstruction.
- Single kidney.
- Cystinuria.
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 |
|---|---|---|
| Tamsulosin | Drug | – |
Primary outcome
stone status at 3 month .
stone free
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2007.
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Flexible vs Semi-rigid URS
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An Intelligent Pressure and Temperature Control Ureteral Soft Scope System for Treating Stones With Infection.
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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.
Mordechai Duvdevani, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamsulosin in people with Upper Tract Ureterolithiasis, run by Hadassah Medical Organization 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 7 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 25 May 2007. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mordechai Duvdevani, MD (0508946816, moti_duv@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone status at 3 month .. The study lists 2 primary outcomes in all. 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 25 May 2007.