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

Kidney Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637519
• Other study ID #: H11-00383
• Status: Completed
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: May 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Hydronephrosis
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis

Locations

Country	Name	City	State
Canada	Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Percutaneous Systems, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-2 weeks following stent placement
Secondary	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.	0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal
Secondary	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.	1-2 weeks following stent placement