Kidney StoneNCT05265936
Is it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?
A study testing Passing a guidewire through a double j stent and Double J stent removal and guidewire insertion in people with Kidney Stone and Ureter Obstruction, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective randomized controlled study, it is aimed to investigate the effects of guidewire advanced through a previously placed double j stent on postoperative complications, operation time and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Stone, Ureter Obstruction, Stent Complication
- What is being tested?
- Passing a guidewire through a double j stent and Double J stent removal and guidewire insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2022to Jul 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Double J stent placed at least 2 weeks ago
Who cannot join
- Active urinary tract infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
Official title: Is it Safe to Advance a Guidewire Through a Previously Deployed Double j Stent? A Prospective, Randomized, Controlled Study
In this prospective randomized controlled study, it is aimed to investigate the effects of guidewire advanced through a previously placed double j stent on postoperative complications, operation time and efficacy.
- Conditions
- Kidney Stone, Ureter Obstruction, Stent Complication
- Being tested
- Passing a guidewire through a double j stent, Double J stent removal and guidewire insertion
- Keywords
- double j stent, guidewire, infection
- Medical subject headings
- Kidney Calculi, Ureteral Obstruction, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passing a guidewire through a double j stentProcedure or surgery
The previously placed double J stent is removed up to the urethral meatus with a cystoscope and forceps and kept fixed at the meatal level without further pulling. Then, after reaching the kidney by passing a guidewire through it, the double j stent is removed. Followed by the routine lithotripsy procedure.
Double J stent removal and guidewire insertionProcedure or surgery
The double j stent is completely removed with the cystoscope and forceps, and the guidwire is inserted into the ureter by visualizing it with the cystoscope. Followed by the routine lithotripsy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Guidewire through DJ stent | Active comparator | Patients who underwent lithotripsy after guidewire insertion through a previously placed double j stent. Receives: Procedure: Passing a guidewire through a double j stent |
| DJ stent remove + guidewire | Sham comparator | Patients who underwent lithotripsy after double j stent removal and guidewire placement. Receives: Procedure: Double J stent removal and guidewire insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative complication
Rate of patients who had a postoperative complication
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265936
- Sponsor's protocol ID
- DJG2022
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leslie SW, Sajjad H. Double J Placement Methods Comparative Analysis. 2023 May 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482453/
PubMed 29494060
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Safe to Advance a Guidewire Through a Previously Deployed Double j Stent? A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05265936
- Acronym / sponsor ID
- DJG2022
- Conditions
- Kidney Stone, Ureter Obstruction, Stent Complication
- Keywords
- double j stent, guidewire, infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 4 Mar 2022 (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.
In this prospective randomized controlled study, it is aimed to investigate the effects of guidewire advanced through a previously placed double j stent on postoperative complications, operation time and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guidewire through DJ stent | Active comparator | Procedure: Passing a guidewire through a double j stentPatients who underwent lithotripsy after guidewire insertion through a previously placed double j stent. |
| DJ stent remove + guidewire | Sham comparator | Procedure: Double J stent removal and guidewire insertionPatients who underwent lithotripsy after double j stent removal and guidewire placement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Double J stent placed at least 2 weeks ago
Key exclusion criteria (1 listed)
- Active urinary tract infection
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 |
|---|---|---|
| Passing a guidewire through a double j stentThe previously placed double J stent is removed up to the urethral meatus with a cystoscope and forceps and kept fixed at the meatal level without further pulling. Then, after reaching the kidney by passing a guidewire through it, the double j stent is removed. Followed by the routine lithotripsy procedure. | Procedure or surgery | Guidewire through DJ stent |
| Double J stent removal and guidewire insertionThe double j stent is completely removed with the cystoscope and forceps, and the guidwire is inserted into the ureter by visualizing it with the cystoscope. Followed by the routine lithotripsy procedure. | Procedure or surgery | DJ stent remove + guidewire |
Primary outcome
Rate of postoperative complication
Time frame: 3 months
Rate of patients who had a postoperative complication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 29494060Leslie SW, Sajjad H. Double J Placement Methods Comparative Analysis. 2023 May 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482453/
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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.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passing a guidewire through a double j stent and Double J stent removal and guidewire insertion in people with Kidney Stone and Ureter Obstruction, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 4 Mar 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Kaan Yildiz (+90 554 773 16 96, alikaanyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative complication (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265936, which also lists 1 linked publication.
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 4 Mar 2022.