Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Percutaneous Systems, Inc.
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01637519
First received: December 13, 2011
Last updated: August 13, 2012
Last verified: August 2012
  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
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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
Study Population

Patients that present with a unilateral, mid- or distal, ureteral stone that require stent placement to relieve stone symptoms

Criteria

Inclusion Criteria:

  1. Perforation of the urinary tract;
  2. Acute hemorrhage;
  3. Tissue trauma;
  4. Edema;
  5. Submucosal tunneling of guidewire or device during advancement; and
  6. Protein encrustation of the device.

    Exclusion Criteria:

  7. Infection;
  8. Hemorrhage;
  9. Complications associated with the use of anesthesia,
  10. Perforation of the urethra or bladder,
  11. Scarring or stricture of the urethra; and
  12. Urinary retention due to urethral edema.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637519

Contacts
Contact: Olga Arsovska, BSc 604-875-4111 ext 62421 olga.arsovska@ubc.ca
Contact: Nathan Hoag, MD natman@interchange.ubc.ca

Locations
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         
Sponsors and Collaborators
University of British Columbia
Percutaneous Systems, Inc.
Investigators
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:
kidney stones
ureteral stones
stent

Additional relevant MeSH terms:
Ureteral Diseases
Calculi
Kidney Calculi
Nephrolithiasis
Hydronephrosis
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on September 18, 2014