Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy

NCT ID: NCT02032316

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-12-31

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.

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).

Conditions

Unilateral Ureteral Stone; Renal Stone Fragments ≤ 2mm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

Placement of ureteral stent following post-ureteroscopy

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Renal stent placed after uncomplicated uteroscopy

Interventions

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

Renal stent placed after uncomplicated uteroscopy

Intervention Type: DEVICE

Other Intervention Names

Renal ureteral stent

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

Adva-Tec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Chew, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

CLIN 14-32-002

Identifier Type: -

Identifier Source: org_study_id