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

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01637519

Collaborator

Percutaneous Systems, Inc. (Industry)

Enrollment

Locations

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones

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

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Relief of hydronephrosis (fluid in kidney causing kidney swelling) [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.

Secondary Outcome Measures

Pain relief [0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal]
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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
2	Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion	Vancouver	British Columbia	Canada

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