Trial record 4 of 34 for:    Open Studies | "Ureteral Diseases"

Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy (URIPRENE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Adva-Tec
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Adva-Tec
ClinicalTrials.gov Identifier:
NCT02032316
First received: January 8, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.


Condition Intervention Phase
Unilateral Ureteral Stone
Renal Stone Fragments ≤ 2mm
Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy

Further study details as provided by Adva-Tec:

Primary Outcome Measures:
  • Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Composite of new-onset serious adverse event(s) including death, infection, the occurrence of surgery, re-hospitalization and or repeat hospitalization related to the device, or device related injury of the ureter.


Secondary Outcome Measures:
  • Technical Success [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology

  • Pain [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire


Estimated Enrollment: 10
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
Placement of ureteral stent following post-ureteroscopy
Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
Renal stent placed after uncomplicated uteroscopy
Other Name: Renal ureteral stent

Detailed Description:

Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment.

Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).

  Eligibility

Ages Eligible for Study:   19 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are > 18, < 80 years of age; inclusive of males and females.
  2. Patients with unilateral ureteral or renal stone fragments < 2mm, post-uncomplicated ureteroscopy (UURS).
  3. Patients with a height and body size able to accommodate a 20, 22, 24, 26, 28, or 30 mm long ureteral stent, as judged by the Investigator.
  4. Patients with the ability to understand the requirements of the study, who have provided written informed consent, and who have agreed to return for the required follow-up assessments.

Exclusion Criteria:

  1. Patients with a known contraindication for treatment with the Uriprene® Stent.
  2. Patients with a history of an anatomical abnormality of the urinary tract.
  3. Patients with a known upper or lower urinary tract infection at the time of stent insertion.
  4. Patients with known renal insufficiency or chronic impairment.
  5. Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent.
  6. Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator.
  7. Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent).
  8. Presence of ureteral blockage or stricture
  9. After failed guide wire placement or failed ureteroscopic access
  10. Impacted ureteral stones still in place
  11. Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy
  12. Patients with a solitary kidney
  13. Presence of ureteral fistula
  14. Presence of ureteral tumor
  15. Presence of extrinsic compression of the ureter
  16. Urinary tract infection
  17. Staghorn calculi
  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: NCT02032316

Contacts
Contact: Jennifer Cartledge + (864) 506-0097 jcartledge@adva-tec.com

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Ben Chew, MD    +1 (604) 875-5046    ben.chew@ubc.ca   
Principal Investigator: Ben Chew, MD         
Sponsors and Collaborators
Adva-Tec
University of British Columbia
Investigators
Principal Investigator: Ben Chew, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Adva-Tec
ClinicalTrials.gov Identifier: NCT02032316     History of Changes
Other Study ID Numbers: CLIN 14-32-002
Study First Received: January 8, 2014
Last Updated: March 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by Adva-Tec:
Renal Stone
Ureteroscopy
Ureteral Stent
post-uncomplicated ureteroscopy
UURS

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

ClinicalTrials.gov processed this record on August 01, 2014