Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy

NCT04565795 | Recruiting DMC FDA Device

• 1 other identifier: CLN 0001
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

Brief Summary

A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.

Conditions

Ureteral Diseases

Keywords

ureteral stent

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours

  Study Success defined as adequate short-term urine drainage, defined as the presence of the stent in the ureter and the lack of surgical or invasive intervention to treat symptoms in the stented ureter during the first 48 hours following placement.

  48 hours

• Primary Safety Endpoint defined as assessment of adverse events through 90 days

  Assessment of Adverse Events through the 90-day follow-up period (incidence, relationship to device and severity) compared to the historical control degradable ureteral stent and plastic ureteral stents

  90 days

Secondary Outcomes (3)

• Overall Clinical Success

  90 days

• Technical success of the device

  90 days

• Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.

  90 days

Study Arms (1)

Placement of ureteral stent post ureteroscopy

EXPERIMENTAL

Subjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS)

Device: Uriprene® Degradable Temporary Ureteral Stent

Interventions

Uriprene® Degradable Temporary Ureteral Stent DEVICE

Assess adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.

Placement of ureteral stent post ureteroscopy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are \>21, \<80 years of age; inclusive of males and females.
• Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
• Subjects with asymptomatic, contralateral renal stones in sizes \<4mm WHICH ARE NOT IN THE RENAL PELVIS OR URETER and who have had uncomplicated ureteroscopy (UURS) can be included. If, during the course of treatment of the target ureter with the Uriprene stent the patient's asymptomatic stone becomes symptomatic and requires treatment, the patient can only be managed with standard of care treatment including the use of an approved ureteral stent, if necessary.
• Subjects 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.
• Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and are willing to undergo all follow-up assessments according to the specified schedule.

You may not qualify if:

• Subjects with a history of an anatomical abnormality of the urinary tract.
• Presence of ureteral fistula.
• Presence of urothelial cancer, ureteral tumor, or renal tumor.
• Presence of extrinsic compression of the ureter.
• Presence of ureteral blockage or stricture.
• Bladder outlet obstruction or neurogenic bladder.
• Subjects with known/diagnosed overactive bladder (OAB).
• Subjects with known/diagnosed urge urinary incontinence (UUI).
• Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion.
• Subjects with creatinine level of ˃2.5 mg/dl.
• Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
• Impacted ureteral stones still in place and/or incomplete stone fragmentation.
• Ureteral perforation.
• Staghorn calculi.
• Subjects with a solitary kidney.

Sponsors & Collaborators

• Adva-Tec: lead
• Northwest Clinical Research Group: collaborator

Study Sites (4)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90404, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Ureteral Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Mitchell Humphreys, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Cartledge, MS

CONTACT

(864) 506-0097; jcartledge@adva-tec.com

Roberta Hines, BS

CONTACT

(425) 766-0308; rhines@nwcrg.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments post-uncomplicated ureteroscopy (UURS).

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: July 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)