Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy

NCT02032316 | Completed Phase 1 DMC

• 1 other identifier: CLIN 14-32-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unilateral Ureteral Stone; Renal Stone Fragments ≤ 2mm

Keywords

Renal Stone; Ureteroscopy; Ureteral Stent; post-uncomplicated ureteroscopy; UURS

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  90 days

Secondary Outcomes (2)

• Technical Success

  90 days

• Pain

  90 days

Study Arms (1)

Interventional

EXPERIMENTAL

Placement of ureteral stent following post-ureteroscopy

Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent

Interventions

Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent DEVICE

Renal stent placed after uncomplicated uteroscopy

Also known as: Renal ureteral stent

Interventional

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are \> 18, \< 80 years of age; inclusive of males and females.
• Patients with unilateral ureteral or renal stone fragments \< 2mm, post-uncomplicated ureteroscopy (UURS).
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Adva-Tec: lead
• University of British Columbia: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Ben Chew, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

CA (1)