Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis
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Purpose
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.
| Condition |
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Kidney Stones |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis |
- Relief of hydronephrosis (fluid in kidney causing kidney swelling) [ Time Frame: 1-2 weeks following stent placement ] [ Designated as safety issue: No ]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.
- Pain relief [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal ] [ Designated as safety issue: No ]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.
- Migration of stent [ Time Frame: 1-2 weeks following stent placement ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Urine
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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.
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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.).
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients that present with a unilateral, mid- or distal, ureteral stone that require stent placement to relieve stone symptoms
Inclusion Criteria:
- Perforation of the urinary tract;
- Acute hemorrhage;
- Tissue trauma;
- Edema;
- Submucosal tunneling of guidewire or device during advancement; and
Protein encrustation of the device.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Olga Arsovska, BSc | 604-875-4111 ext 62421 | olga.arsovska@ubc.ca |
| Contact: Nathan Hoag, MD | natman@interchange.ubc.ca |
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Olga Arsovska, BSc 604-875-4111 ext 62421 olga.arsovska@ubc.ca | |
| Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Olga Arsovska, BSc 604-875-4111 ext 62421 olga.arsovska@ubc.ca | |
| Principal Investigator: Ben Chew, MD,MSc,FRCSC | |
| Principal Investigator: | Ben H Chew, MD | University of British Columbia, Vancouver General Hospital |
| Study Director: | Ryan F Paterson, MD | University of British Columbia, Vancouver General Hospital |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01637519 History of Changes |
| Other Study ID Numbers: | H11-00383 |
| Study First Received: | December 13, 2011 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
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kidney stones ureteral stones stent |
Additional relevant MeSH terms:
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Calculi Hydronephrosis Kidney Calculi Nephrolithiasis Ureteral Calculi Ureterolithiasis |
Pathological Conditions, Anatomical Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Ureteral Diseases |
ClinicalTrials.gov processed this record on May 16, 2013