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

Adva-Tec

Status and phase: Completed; Phase 1

Conditions: Unilateral Ureteral Stone; Renal Stone Fragments ≤ 2mm

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02032316

CLIN 14-32-002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Interventional

Experimental group

Description:

Placement of ureteral stent following post-ureteroscopy

Treatment:

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