Clinical trial NCT01637519: Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis
Official title: Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stones
Keywords: kidney stones
ureteral stones
stent
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Percutaneous Systems, Inc.
First posted: 2012-07-11
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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. 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.).

Eligibility 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.

Primary outcomes:
measure: Relief of hydronephrosis (fluid in kidney causing kidney swelling)
timeFrame: 1-2 weeks following stent placement
Secondary outcomes:
measure: Pain relief
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal
measure: Migration of stent
timeFrame: 1-2 weeks following stent placement
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
state: British Columbia
Study officials:
affiliation: University of British Columbia, Vancouver General Hospital
name: Ben H Chew, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia, Vancouver General Hospital
name: Ryan F Paterson, MD
role: STUDY_DIRECTOR
References: