Urinary StoneNCT03108053
Results of Safety Guidewire Use in Ureteroscopic Stone Surgery
A study testing Semirigid Ureteroscopy (URS) With Guide Wire and Semirigid Ureteroscopy (URS) Without Guide Wire in people with Urinary Stone, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in ureteroscopy and recommended its routine use. However, the necessity of SGW placement in endourological procedures lack evidence and is being suggested as an expert opinion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Stone
- What is being tested?
- Semirigid Ureteroscopy (URS) With Guide Wire and Semirigid Ureteroscopy (URS) Without Guide Wire
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2014to 1 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ureteral stone disease patients who would undergo ureteroscopy procedure
Who cannot join
- Patients who have a medical condition that makes randomisation not possible
- Patients in whose operations safety guidewire is regarded as a necessity
- Patients who refuse to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine
Pendik
Yiloren Tanidir, yiloren@yahoo.com
Bahadir Sahin, drbahadirsahin@gmail.com
About this study
Official title: Results of a Prospective Randomized Trial of Safety Guidewire Use in Ureteroscopic Stone Surgery: to Use or Not to Use
Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in ureteroscopy and recommended its routine use. However, the necessity of SGW placement in endourological procedures lack evidence and is being suggested as an expert opinion. Present study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral stones with semi-rigid ureteroscopy (s-URS).
For this purpose patients with ureteral stones are being stratified according to ureteral stone location and prospectively randomized into two groups' according to SGW usage or not in s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr (Olympus) and laser. Chi-square and student t-test were used for comparing data.
- Conditions
- Urinary Stone
- Being tested
- Semirigid Ureteroscopy (URS) With Guide Wire, Semirigid Ureteroscopy (URS) Without Guide Wire
- Keywords
- urinary stones, semirigid ureteroscopy, guidewire
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semirigid Ureteroscopy (URS) With Guide WireProcedure or surgery
Semirigid URS is the operations used for ureteral stone disease. In routine practice it is most commonly done with the use of a guide wire. It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.
Semirigid Ureteroscopy (URS) Without Guide WireDevice
Semirigid URS is the operations used for ureteral stone disease . It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.
| Study group | Role | What they receive |
|---|---|---|
| Guidewire used | Active comparator | Patients whose semirigid ureteroscopy procedure is conducted with the use of safety guidewire Receives: Procedure: Semirigid Ureteroscopy (URS) With Guide Wire |
| No guide wire used | Experimental | Patients whose semirigid ureteroscopy procedure is conducted without the use of safety guidewire Receives: Device: Semirigid Ureteroscopy (URS) Without Guide Wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rates
Measured: Post operative 3 months (12 weeks after surgery)
Secondary outcomes (3)
Operation duration of surgery
Measured: the duration of surgical procedure
Late Complication rate
Measured: Post operative 3 months (12 weeks after surgery)
Early Complication rate
Measured: Post operative 3 days (up to 3 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 posted11 Apr 2017
- Study start1 Jun 2014
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary StoneStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108053
- Sponsor's protocol ID
- MAR.UAD.001
- Other IDs
- 09.2017.098
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of a Prospective Randomized Trial of Safety Guidewire Use in Ureteroscopic Stone Surgery: to Use or Not to Use
- ClinicalTrials.gov ID
- NCT03108053
- Acronym / sponsor ID
- MAR.UAD.001
- Conditions
- Urinary Stone
- Keywords
- urinary stones, semirigid ureteroscopy, guidewire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 11 Apr 2017 (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.
Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in ureteroscopy and recommended its routine use. However, the necessity of SGW placement in endourological procedures lack evidence and is being suggested as an expert opinion. Present study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral stones with semi-rigid ureteroscopy (s-URS).
For this purpose patients with ureteral stones are being stratified according to ureteral stone location and prospectively randomized into two groups' according to SGW usage or not in s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr (Olympus) and laser. Chi-square and student t-test were used for comparing data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guidewire used | Active comparator | Procedure: Semirigid Ureteroscopy (URS) With Guide WirePatients whose semirigid ureteroscopy procedure is conducted with the use of safety guidewire |
| No guide wire used | Experimental | Device: Semirigid Ureteroscopy (URS) Without Guide WirePatients whose semirigid ureteroscopy procedure is conducted without the use of safety guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ureteral stone disease patients who would undergo ureteroscopy procedure
Key exclusion criteria (3 listed)
- Patients who have a medical condition that makes randomisation not possible
- Patients in whose operations safety guidewire is regarded as a necessity
- Patients who refuse to participate
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 |
|---|---|---|
| Semirigid Ureteroscopy (URS) With Guide WireSemirigid URS is the operations used for ureteral stone disease. In routine practice it is most commonly done with the use of a guide wire. It is conducted with ureteroscope and stone is disintegrated most commonly with lasers. | Procedure or surgery | Guidewire used |
| Semirigid Ureteroscopy (URS) Without Guide WireSemirigid URS is the operations used for ureteral stone disease . It is conducted with ureteroscope and stone is disintegrated most commonly with lasers. | Device | No guide wire used |
Primary outcome
Stone free rates
Time frame: Post operative 3 months (12 weeks after surgery)
3 secondary outcomes
Operation duration of surgery
Time frame: the duration of surgical procedure
Late Complication rate
Time frame: Post operative 3 months (12 weeks after surgery)
Early Complication rate
Time frame: Post operative 3 days (up to 3 days after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semirigid Ureteroscopy (URS) With Guide Wire and Semirigid Ureteroscopy (URS) Without Guide Wire in people with Urinary Stone, run by Marmara University 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 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rates (time frame: Post operative 3 months (12 weeks 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 Mar 2019.