Kidney StonesNCT01637519
Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis
An observational study of Kidney Stones, run by University of British Columbia at 2 sites in Canada.
Trial summary
Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that drains the bladder), require urgent treatment with a stent to relieve the blockage. This tube, or ureteral stent, gives the patient relief until they can have their stone treated. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Stones
- How many people
- 9 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2012to Sep 2015
- Phase
- Observational
- 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
Study population: Patients that present with a unilateral, mid- or distal, ureteral stone that require stent placement to relieve stone symptoms
Who may be able to join
- Perforation of the urinary tract;
- Acute hemorrhage;
- Tissue trauma;
- Edema;
- Submucosal tunneling of guidewire or device during advancement; and
- Protein encrustation of the device.
Who cannot join
- Infection;
- Hemorrhage;
- Complications associated with the use of anesthesia,
- Perforation of the urethra or bladder,
- Scarring or stricture of the urethra; and
- Urinary retention due to urethral edema.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
Vancouver, British Columbia
About this study
Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that drains the bladder), require urgent treatment with a stent to relieve the blockage. This tube, or ureteral stent, gives the patient relief until they can have their stone treated. This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones. This stent is designed to drain the kidney and unlike other ureteral stents, is also designed to widen the ureter to help the stone pass on its own.
Read the detailed description
This study is to evaluate a new type of ureteral stent to relieve kidney obstruction from a stone lodged in the ureter. This stent would be placed when a patient presents with pain in the Emergency Room or clinic in a patient that has no signs of infection. It is designed to continue drainage of the kidney and unlike other ureteral stents, is also designed to help dilate the ureter to facilitate spontaneous stone passage. This means the stent may also be therapeutic and the patient would be less likely to undergo another procedure to have the stone removed. Research performed at the Stone Centre at VGH shows that in ex vivo pig kidneys, this stent provides very good urinary drainage of the kidney. This has been published in a peer-reviewed journal (Lange D, Hoag NA, Poh BK, Chew BH. Drainage characteristics of the 3F MicroStent using a novel film occlusion anchoring mechanism. J Endourol. 2011 Jun;25(6):1051-6.).
- Conditions
- Kidney Stones
- Keywords
- kidney stones, ureteral stones, stent
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ureteral stone | Ten (10) patients with a unilateral, mid- or distal, ureteral (tube connecting kidney and bladder in the urinary system) stone will be enrolled and brought to completion in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of hydronephrosis (fluid in kidney causing kidney swelling)
Patients will return for radiographic test(s) after the stent placement as determined by the physician which can include kidney-ureter-bladder (KUB) x-ray, renal and bladder ultrasound, or CT scan. This imaging helps determine 2 things: the degree of kidney swelling (hydronephrosis), stent migration and whether their stone is still present or not.
Measured: 1-2 weeks following stent placement
Secondary outcomes (2)
Pain relief
Before stent placement the subject will complete Visual Analog Scale (VAS) questionnaire. After stent placement and discharge home study questionnaires will be completed each day at the end of the day, until stent removal which will be in approximately 7 days. Each VAS questionnaire takes approximately 10 minutes to complete. The subject will be instructed to bring these at their clinic visit for stent removal at Vancouver General Hospital. After the stent removal 2 more questionnaires are completed, at 1 day and at 7 days. These are sent back in a stamped return envelope.
Measured: 0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal
Migration of stent
Patients will return for radiographic test(s) after the stent placement as determined by the physician which can include kidney-ureter-bladder (KUB) x-ray, renal and bladder ultrasound, or CT scan. This imaging helps determine 2 things: the degree of kidney swelling (hydronephrosis), stent migration and whether their stone is still present or not.
Measured: 1-2 weeks following stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Percutaneous Systems, Inc.
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben H Chew, MD, Principal investigator, University of British Columbia, Vancouver General HospitalRyan F Paterson, MD, Study director, University of British Columbia, Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637519
- Sponsor's protocol ID
- H11-00383
- Status last verified
- May 2018
- First submitted
- 13 Dec 2011
- 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
- Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis
- ClinicalTrials.gov ID
- NCT01637519
- Acronym / sponsor ID
- H11-00383
- Conditions
- Kidney Stones
- Keywords
- kidney stones, ureteral stones, stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Percutaneous Systems, Inc.
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Jul 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.
Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that drains the bladder), require urgent treatment with a stent to relieve the blockage. This tube, or ureteral stent, gives the patient relief until they can have their stone treated. This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones. This stent is designed to drain the kidney and unlike other ureteral stents, is also designed to widen the ureter to help the stone pass on its own.
Detailed description
This study is to evaluate a new type of ureteral stent to relieve kidney obstruction from a stone lodged in the ureter. This stent would be placed when a patient presents with pain in the Emergency Room or clinic in a patient that has no signs of infection. It is designed to continue drainage of the kidney and unlike other ureteral stents, is also designed to help dilate the ureter to facilitate spontaneous stone passage. This means the stent may also be therapeutic and the patient would be less likely to undergo another procedure to have the stone removed. Research performed at the Stone Centre at VGH shows that in ex vivo pig kidneys, this stent provides very good urinary drainage of the kidney. This has been published in a peer-reviewed journal (Lange D, Hoag NA, Poh BK, Chew BH. Drainage characteristics of the 3F MicroStent using a novel film occlusion anchoring mechanism. J Endourol. 2011 Jun;25(6):1051-6.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ureteral stone | – | –Ten (10) patients with a unilateral, mid- or distal, ureteral (tube connecting kidney and bladder in the urinary system) stone will be enrolled and brought to completion in this study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that present with a unilateral, mid- or distal, ureteral stone that require stent placement to relieve stone symptoms
Key inclusion criteria (6 listed)
- Perforation of the urinary tract;
- Acute hemorrhage;
- Tissue trauma;
- Edema;
- Submucosal tunneling of guidewire or device during advancement; and
Key exclusion criteria (6 listed)
- Infection;
- Hemorrhage;
- Complications associated with the use of anesthesia,
- Perforation of the urethra or bladder,
- Scarring or stricture of the urethra; and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relief of hydronephrosis (fluid in kidney causing kidney swelling)
Time frame: 1-2 weeks following stent placement
Patients will return for radiographic test(s) after the stent placement as determined by the physician which can include kidney-ureter-bladder (KUB) x-ray, renal and bladder ultrasound, or CT scan. This imaging helps determine 2 things: the degree of kidney swelling (hydronephrosis), stent migration and whether their stone is still present or not.
2 secondary outcomes
Pain relief
Time frame: 0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal
Migration of stent
Time frame: 1-2 weeks following stent placement
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
Related trials for Kidney Stones
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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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 H Chew, MD principal investigator
University of British Columbia, Vancouver General Hospital
Ryan F Paterson, MD study director
University of British Columbia, Vancouver General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones, run by University of British Columbia at 2 sites 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 6 inclusion and 6 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 2 sites 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?
Relief of hydronephrosis (fluid in kidney causing kidney swelling) (time frame: 1-2 weeks following stent placement). 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.