UrolithiasisNCT01117688
Ureteroscopy With and Without Safety Guidewire
A study testing Ureteroscopy with and without safety guidewire in people with Urolithiasis, run by Helse-Bergen HF at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis. Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Ureteroscopy with and without safety guidewire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- May 2010to Dec 2012
- 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
- Patients with urolithiasis planned for ureterorenoscopic treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Helse Bergen HF, Haukeland University Hospital
Bergen, Bergen, 5021
About this study
Official title: Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.
The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.
Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.
Read the detailed description
The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.
However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.
The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.
- Conditions
- Urolithiasis
- Being tested
- Ureteroscopy with and without safety guidewire
- Keywords
- Ureteroscopy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopy with and without safety guidewireProcedure or surgery
In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.
| Study group | Role | What they receive |
|---|---|---|
| B - without SGW | Active comparator | Ureteroscopy without SGW in place. Receives: Procedure: Ureteroscopy with and without safety guidewire |
| A - with SGW | Active comparator | Ureteroscopy with SGW in place. Receives: Procedure: Ureteroscopy with and without safety guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free-rate
Measured: 3 months after treatment
Secondary outcomes (3)
Hospital stay
Measured: Up to 1 week after the operation
Complication rate
Measured: Until 3 months after the procedure
Operating time
Measured: Up to 1 day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Withdrawn. Not enough time to go through with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse-Bergen HF
- Sponsor type
- University, hospital or other
- Investigators
- Øyvind Ulvik, MD, Principal investigator, Helse Bergen HF, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117688
- Sponsor's protocol ID
- 102.09 (REK) - 3
- Other IDs
- 21835 (NSD) - 3, 102.09 (REK) - 3
- Status last verified
- Jun 2011
- First submitted
- 4 May 2010
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.
- ClinicalTrials.gov ID
- NCT01117688
- Acronym / sponsor ID
- 102.09 (REK) - 3
- Conditions
- Urolithiasis
- Keywords
- Ureteroscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn. Not enough time to go through with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helse-Bergen HFUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 May 2010 (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 investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.
Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.
Detailed description
The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.
However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.
The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B - without SGW | Active comparator | Procedure: Ureteroscopy with and without safety guidewireUreteroscopy without SGW in place. |
| A - with SGW | Active comparator | Procedure: Ureteroscopy with and without safety guidewireUreteroscopy with SGW in place. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with urolithiasis planned for ureterorenoscopic treatment
Key exclusion criteria (0 listed)
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 and without safety guidewireIn study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW. | Procedure or surgery | A - with SGW, B - without SGW |
Primary outcome
Stone free-rate
Time frame: 3 months after treatment
3 secondary outcomes
Hospital stay
Time frame: Up to 1 week after the operation
Complication rate
Time frame: Until 3 months after the procedure
Operating time
Time frame: Up to 1 day after the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Øyvind Ulvik, MD principal investigator
Helse Bergen HF, Haukeland University 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 Ureteroscopy with and without safety guidewire in people with Urolithiasis, run by Helse-Bergen HF at 1 site in Norway.
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 0 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: withdrawn, as of the sponsor's last update on 1 Apr 2015. 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 Norway. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 treatment). 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 1 Apr 2015.