Ureteral CalculiNCT03726502
Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone
A study testing ureteroscopy with safety guide-wire, ureteroscopy alone and without safety guide-wire in people with Ureteral Calculi, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- ureteroscopy with safety guide-wire, ureteroscopy alone and without safety guide-wire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIran
- Study dates
- 1 Apr 2017to 1 Apr 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ureteral stone who underwent ureteroscopy
Who cannot join
- transplant kidney
- coagulopathy disorders
- history of ureteral stenosis
- skeletal disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone
Read the detailed description
While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone
- Conditions
- Ureteral Calculi
- Being tested
- ureteroscopy with safety guide-wire, ureteroscopy alone, without safety guide-wire, with safety guide-wire
- Keywords
- Ureteral Calculi, safety guide-wire, ureteroscopy
- Medical subject headings
- Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ureteroscopy with safety guide-wireProcedure or surgery
ureteroscopy with use of safety guide-wire in treatment of ureteral stone
ureteroscopy aloneProcedure or surgery
ureteroscopy without use of safety guide-wire in treatment of ureteral stone
without safety guide-wireProcedure or surgery
ureteroscopy without use of safety guide-wire in treatment of ureteral stone
with safety guide-wireProcedure or surgery
ureteroscopy with use of safety guide-wire in treatment of ureteral stone
| Study group | Role | What they receive |
|---|---|---|
| ureteroscopy with safety guide-wire | Active comparator | ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy Receives: Procedure: ureteroscopy with safety guide-wire; Procedure: with safety guide-wire |
| ureteroscopy alone | Placebo comparator | ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy Receives: Procedure: ureteroscopy alone; Procedure: without safety guide-wire |
| with safety guide-wire | Active comparator | ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy Receives: Procedure: ureteroscopy with safety guide-wire; Procedure: with safety guide-wire |
| without safety guide-wire | Placebo comparator | ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy Receives: Procedure: ureteroscopy alone; Procedure: without safety guide-wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
rate of patients without any residue of stone
Measured: 3 months after surgery
Secondary outcomes (3)
operation time
the time between insertion of ureteroscopy till insertion of catheter
Measured: at time of surgery
grade of kidney hydronephrosis
grade of hydronephrosis is classified as: 0-4 grades
Measured: 3 months after surgery
ureteral injury
ureteral injury is classified as: Mucosal abrasion, Ureteral perforation, Intussusception / avulsion
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Apr 2017
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Shemshaki, Isfahan University of Medical Sciences
- Investigators
- Abbas Basiri, prof, Study chair, Shahid beheshty university of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726502
- Sponsor's protocol ID
- Q12133
- Status last verified
- Oct 2018
- First submitted
- 19 Apr 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone
- ClinicalTrials.gov ID
- NCT03726502
- Acronym / sponsor ID
- Q12133
- Conditions
- Ureteral Calculi
- Keywords
- Ureteral Calculi, safety guide-wire, ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 31 Oct 2018 (actual)
- 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 compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone
Detailed description
While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ureteroscopy with safety guide-wire | Active comparator | Procedure: ureteroscopy with safety guide-wire, Procedure: with safety guide-wireureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy |
| ureteroscopy alone | Placebo comparator | Procedure: ureteroscopy alone, Procedure: without safety guide-wireureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy |
| with safety guide-wire | Active comparator | Procedure: ureteroscopy with safety guide-wire, Procedure: with safety guide-wireureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy |
| without safety guide-wire | Placebo comparator | Procedure: ureteroscopy alone, Procedure: without safety guide-wireureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ureteral stone who underwent ureteroscopy
Key exclusion criteria (4 listed)
- transplant kidney
- coagulopathy disorders
- history of ureteral stenosis
- skeletal disorders
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 with safety guide-wireureteroscopy with use of safety guide-wire in treatment of ureteral stone | Procedure or surgery | ureteroscopy with safety guide-wire, with safety guide-wire |
| ureteroscopy aloneureteroscopy without use of safety guide-wire in treatment of ureteral stone | Procedure or surgery | ureteroscopy alone, without safety guide-wire |
| without safety guide-wireureteroscopy without use of safety guide-wire in treatment of ureteral stone | Procedure or surgery | ureteroscopy alone, without safety guide-wire |
| with safety guide-wireureteroscopy with use of safety guide-wire in treatment of ureteral stone | Procedure or surgery | ureteroscopy with safety guide-wire, with safety guide-wire |
Primary outcome
stone free rate
Time frame: 3 months after surgery
rate of patients without any residue of stone
3 secondary outcomes
operation time
Time frame: at time of surgery
grade of kidney hydronephrosis
Time frame: 3 months after surgery
ureteral injury
Time frame: at time of 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 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Ureteral Access Strategies in Retrograde Intrarenal Surgery
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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.
Abbas Basiri, prof study chair
Shahid beheshty university of medical sciences
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 with safety guide-wire, ureteroscopy alone and without safety guide-wire in people with Ureteral Calculi, run by Isfahan 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 4 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 19 Dec 2018. 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.
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 19 Dec 2018.