Kidney StonePhase 2NCT02751281
Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones
A Phase 2 study testing Pneumatic percutaneous nephrolithotomy and Ultra-sonic percutaneous nephrolithotomy in people with Kidney Stone, run by Isfahan University of Medical Sciences.
Trial summary
The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Pneumatic percutaneous nephrolithotomy and Ultra-sonic percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Apr 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with >2cm kidney stone
Who cannot join
- Pregnant women
- patients with coagulopathies
- patients with scattered stones who needed several accesses
About this study
The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones
Read the detailed description
While there are several retrospective studies evaluating the efficacy of different lithotripter in percutaneous nephrolithotomy, there are few prospective studies in this regard. This study was designed to compare the efficacy and safety of Ultrasonic versus pneumatic percutaneous nephrolithotomy in treatment of large kidney stones.
- Conditions
- Kidney Stone
- Being tested
- Pneumatic percutaneous nephrolithotomy, Ultra-sonic percutaneous nephrolithotomy
- Keywords
- pneumatic, ultra-sonic, percutaneous nephrolithotomy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic percutaneous nephrolithotomyProcedure or surgery
Pneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone
Ultra-sonic percutaneous nephrolithotomyProcedure or surgery
Ultra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone
| Study group | Role | What they receive |
|---|---|---|
| pneumatic percutaneous nephrolithotomy | Active comparator | pneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone Receives: Procedure: Pneumatic percutaneous nephrolithotomy |
| Ultra-sonic percutaneous nephrolithotomy | Active comparator | Ultra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone Receives: Procedure: Ultra-sonic percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
Measured: 3 months after surgery
Secondary outcomes (1)
hemoglobin loss
Measured: 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Hamidreza Shemshaki, Isfahan University of Medical Sciences
- Investigators
- Nasser Simforoosh, Prof, Study chair, Shahid Beheshty University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751281
- Sponsor's protocol ID
- ASD-100
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones
- ClinicalTrials.gov ID
- NCT02751281
- Acronym / sponsor ID
- ASD-100
- Conditions
- Kidney Stone
- Keywords
- pneumatic, ultra-sonic, percutaneous nephrolithotomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Apr 2016 (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 determine which type of percutaneous nephrolithotomy is better in large kidney stones
Detailed description
While there are several retrospective studies evaluating the efficacy of different lithotripter in percutaneous nephrolithotomy, there are few prospective studies in this regard. This study was designed to compare the efficacy and safety of Ultrasonic versus pneumatic percutaneous nephrolithotomy in treatment of large kidney stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pneumatic percutaneous nephrolithotomy | Active comparator | Procedure: Pneumatic percutaneous nephrolithotomypneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone |
| Ultra-sonic percutaneous nephrolithotomy | Active comparator | Procedure: Ultra-sonic percutaneous nephrolithotomyUltra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with >2cm kidney stone
Key exclusion criteria (3 listed)
- Pregnant women
- patients with coagulopathies
- patients with scattered stones who needed several accesses
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 |
|---|---|---|
| Pneumatic percutaneous nephrolithotomyPneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone | Procedure or surgery | pneumatic percutaneous nephrolithotomy |
| Ultra-sonic percutaneous nephrolithotomyUltra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone | Procedure or surgery | Ultra-sonic percutaneous nephrolithotomy |
Primary outcome
stone free rate
Time frame: 3 months after surgery
1 secondary outcome
hemoglobin loss
Time frame: 2 days 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 26 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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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.
Nasser Simforoosh, Prof study chair
Shahid Beheshty University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pneumatic percutaneous nephrolithotomy and Ultra-sonic percutaneous nephrolithotomy in people with Kidney Stone, run by Isfahan University of Medical Sciences.
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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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: 3 months 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 26 Apr 2016.