Renal Pelvis Stone >3cmPhase 2/3NCT01637337
Laparoscopic Pyelolithotomy Versus Percutaneous Nephrolothotomy for Management of >3cm Renal Pelvis Stone
A Phase 2/3 study testing laparoscopic pyelolithotomy and percutaneous nephrolithotomy in people with Renal Pelvis Stone >3cm, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with >3cm renal pelvis stone. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Renal Pelvis Stone >3cm
- What is being tested?
- laparoscopic pyelolithotomy and percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Jan 2013
- Phase
- Phase 2/3
- 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
- Adults with >3cm renal pelvis stone
Who cannot join
- History of previous surgery on the target kidney
- Active UTI
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with >3cm renal pelvis stone.
- Conditions
- Renal Pelvis Stone >3cm
- Being tested
- laparoscopic pyelolithotomy, percutaneous nephrolithotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic pyelolithotomyProcedure or surgery
laparoscopy
percutaneous nephrolithotomyProcedure or surgery
percutaneous nephrolithotomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic pyelolithotomy | Active comparator | Not described Receives: Procedure: laparoscopic pyelolithotomy |
| percutaneous nephrolithotomy | Sham comparator | Not described Receives: Procedure: percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Measured: at least 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Pelvis Stone >3cmStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Aminsharifi, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637337
- Sponsor's protocol ID
- 89-01-01-2391
- Status last verified
- Apr 2016
- First submitted
- 3 Jul 2012
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Pyelolithotomy Versus Percutaneous Nephrolothotomy for Management of >3cm Renal Pelvis Stone
- ClinicalTrials.gov ID
- NCT01637337
- Acronym / sponsor ID
- 89-01-01-2391
- Conditions
- Renal Pelvis Stone >3cm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Jul 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.
To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with >3cm renal pelvis stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic pyelolithotomy | Active comparator | Procedure: laparoscopic pyelolithotomy |
| percutaneous nephrolithotomy | Sham comparator | Procedure: percutaneous nephrolithotomy |
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)
- Adults with >3cm renal pelvis stone
Key exclusion criteria (3 listed)
- History of previous surgery on the target kidney
- Active UTI
- Coagulopathy
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 |
|---|---|---|
| laparoscopic pyelolithotomylaparoscopy | Procedure or surgery | laparoscopic pyelolithotomy |
| percutaneous nephrolithotomypercutaneous nephrolithotomy | Procedure or surgery | percutaneous nephrolithotomy |
Primary outcome
Stone free rate
Time frame: at least 6 month after surgery
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 20 Apr 2016.
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 Phase 2/3 study testing laparoscopic pyelolithotomy and percutaneous nephrolithotomy in people with Renal Pelvis Stone >3cm, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 3 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 20 Apr 2016. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Stone free rate (time frame: at least 6 month after surgery). 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 20 Apr 2016.