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

NCT01637519 | Completed DMC

• 1 other identifier: H11-00383
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Stones

Keywords

kidney stones; ureteral stones; stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain relief

  0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal

• Migration of stent

  1-2 weeks following stent placement

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Perforation of the urinary tract;
• Acute hemorrhage;
• Tissue trauma;
• Edema;
• Submucosal tunneling of guidewire or device during advancement; and
• Protein encrustation of the device.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Percutaneous Systems, Inc.: collaborator

Study Sites (2)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion

Vancouver, British Columbia, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben H Chew, MD

  University of British Columbia, Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

• Ryan F Paterson, MD

  University of British Columbia, Vancouver General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: July 11, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)