Kidney CalculiNCT01739725
Study Evaluating the Helical Ureteral Stent
A study testing Stent insertion in people with Kidney Calculi, run by University of British Columbia at 1 site in Canada.
Trial summary
The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Stent insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Dec 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
- 19 years of age and older
- Having undergone Shockwave Lithotripsy-SWL, or a diagnostic ureteroscopy or uncomplicated ureteroscopy for stone removal requiring retrograde placement of a ureteral stent for an anticipated duration of between 2 and 21 days
- Willing to sign the Informed Consent Form
- Able to read, understand, and complete patient questionnaires
Who cannot join
- Active, symptomatic urinary tract infection
- Non-stone related distal ureteral obstruction or stricture
- Clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort
- Ureteral perforation or trauma
- History of bladder reconstruction or interstitial cystitis
- Spinal cord injuries
- 6. Pregnant or lactating females 7. Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively 8. Patients with a solitary kidney 9. Chronic use of pain or anti-spasmodic medication for symptoms other than stone related pain 10. If in the opinion of the Investigator, the patient is not a suitable study candidate.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z1M9
About this study
Official title: A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent
The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers.
Read the detailed description
Ureteral stents have been used for many years for a variety of clinical indications. Many surgeons routinely use ureteral stents after the endourologic removal of stones to facilitate in urine passage and facilitate excretion of any left over stones. There is a multitude of literature that reveals that most patients find ureteral stents to be uncomfortable. This discomfort often causes pain severe enough that patients anxiously anticipate stent removal, and often request early stent removal, and/or require use of pain medications that have many side effects and cause further discomfort to these patients.
- Conditions
- Kidney Calculi
- Being tested
- Stent insertion
- Keywords
- kidney stones, ureteral stent, pain,
- Medical subject headings
- Kidney Calculi, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent insertionDevice
The patient will receive the helical stent
| Study group | Role | What they receive |
|---|---|---|
| Helical stent insertion | Experimental | Study participants will receive the helical stent Receives: Device: Stent insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients who have pain during the stent indwell period
The primary objective is to decrease the percent of patients who have pain during the stent indwell period beyond protocol-defined postoperative pain therapy from 25% for standard stents (the Control Stent in previous studies) to 10% for the Helical Stent. The previous clinical trial found that patients with Percuflex Plus stents had pain 25.2% of the time following stent insertion (J Urol 183:1037, 2010).
Measured: 1-2 weeks
Secondary outcomes (1)
Percent of patients requesting intervention during the stent indwell period
The secondary objective is to decrease the percent of patients requesting intervention during the stent indwell period.
Interventions are defined as the following actions taken due to pain:
- Unscheduled Clinic visit, or
- Change in Pain Medication, or
- Early Stent Removal
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben Chew, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739725
- Sponsor's protocol ID
- H11-03073
- Status last verified
- May 2018
- First submitted
- 29 Nov 2012
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent
- ClinicalTrials.gov ID
- NCT01739725
- Acronym / sponsor ID
- H11-03073
- Conditions
- Kidney Calculi
- Keywords
- kidney stones, ureteral stent, pain,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Dec 2012 (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 Boston Scientific Helical Stent is a unique stent designed to improve flexibility and comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers.
Detailed description
Ureteral stents have been used for many years for a variety of clinical indications. Many surgeons routinely use ureteral stents after the endourologic removal of stones to facilitate in urine passage and facilitate excretion of any left over stones. There is a multitude of literature that reveals that most patients find ureteral stents to be uncomfortable. This discomfort often causes pain severe enough that patients anxiously anticipate stent removal, and often request early stent removal, and/or require use of pain medications that have many side effects and cause further discomfort to these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helical stent insertion | Experimental | Device: Stent insertionStudy participants will receive the helical stent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
- 19 years of age and older
- Having undergone Shockwave Lithotripsy-SWL, or a diagnostic ureteroscopy or uncomplicated ureteroscopy for stone removal requiring retrograde placement of a ureteral stent for an anticipated duration of between 2 and 21 days
- Willing to sign the Informed Consent Form
- Able to read, understand, and complete patient questionnaires
Key exclusion criteria (7 listed)
- Active, symptomatic urinary tract infection
- Non-stone related distal ureteral obstruction or stricture
- Clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort
- Ureteral perforation or trauma
- History of bladder reconstruction or interstitial cystitis
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 |
|---|---|---|
| Stent insertionThe patient will receive the helical stent | Device | Helical stent insertion |
Primary outcome
Percent of patients who have pain during the stent indwell period
Time frame: 1-2 weeks
The primary objective is to decrease the percent of patients who have pain during the stent indwell period beyond protocol-defined postoperative pain therapy from 25% for standard stents (the Control Stent in previous studies) to 10% for the Helical Stent. The previous clinical trial found that patients with Percuflex Plus stents had pain 25.2% of the time following stent insertion (J Urol 183:1037, 2010).
1 secondary outcome
Percent of patients requesting intervention during the stent indwell period
Time frame: 1-2 weeks
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 9 May 2018.
- 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.
Ben Chew, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent insertion in people with Kidney Calculi, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 7 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 9 May 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 Canada. 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 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?
Percent of patients who have pain during the stent indwell period (time frame: 1-2 weeks). 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 9 May 2018.