RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy

Quick Facts

Study Start:2022-07-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04565795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects who are \>21, \<80 years of age; inclusive of males and females. 2. Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS). 3. 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. 4. 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. 5. 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.	1. Subjects with a history of an anatomical abnormality of the urinary tract. 2. Presence of ureteral fistula. 3. Presence of urothelial cancer, ureteral tumor, or renal tumor. 4. Presence of extrinsic compression of the ureter. 5. Presence of ureteral blockage or stricture. 6. Bladder outlet obstruction or neurogenic bladder. 7. Subjects with known/diagnosed overactive bladder (OAB). 8. Subjects with known/diagnosed urge urinary incontinence (UUI). 9. Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion. 10. Subjects with creatinine level of ˃2.5 mg/dl. 11. 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. 12. Impacted ureteral stones still in place and/or incomplete stone fragmentation. 13. Ureteral perforation. 14. Staghorn calculi. 15. Subjects with a solitary kidney. 16. History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed). 17. Contrast allergy that cannot be adequately pre-treated. 18. Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions or unable to reliably complete patient questionnaires. 19. Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent. 20. Subject has a known significant concomitant illness with a life expectancy of \<1 year. 21. Subject is known to be currently enrolled in another investigational trial.

Inclusion Criteria

Exclusion Criteria

1. Subjects who are \>21, \<80 years of age; inclusive of males and females.
2. Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
3. 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.
4. 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.
5. 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.

1. Subjects with a history of an anatomical abnormality of the urinary tract.
2. Presence of ureteral fistula.
3. Presence of urothelial cancer, ureteral tumor, or renal tumor.
4. Presence of extrinsic compression of the ureter.
5. Presence of ureteral blockage or stricture.
6. Bladder outlet obstruction or neurogenic bladder.
7. Subjects with known/diagnosed overactive bladder (OAB).
8. Subjects with known/diagnosed urge urinary incontinence (UUI).
9. Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion.
10. Subjects with creatinine level of ˃2.5 mg/dl.
11. 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.
12. Impacted ureteral stones still in place and/or incomplete stone fragmentation.
13. Ureteral perforation.
14. Staghorn calculi.
15. Subjects with a solitary kidney.
16. History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed).
17. Contrast allergy that cannot be adequately pre-treated.
18. Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions or unable to reliably complete patient questionnaires.
19. Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.
20. Subject has a known significant concomitant illness with a life expectancy of \<1 year.
21. Subject is known to be currently enrolled in another investigational trial.

Contacts and Locations

Study Contact

Jennifer Cartledge, MS

CONTACT

(864) 506-0097

jcartledge@adva-tec.com

Roberta Hines, BS

CONTACT

(425) 766-0308

rhines@nwcrg.com

Principal Investigator

Mitchell Humphreys, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Arizona

Phoenix, Arizona, 85054

United States

University of California Los Angeles

Los Angeles, California, 90404

United States

University of California San Diego

San Diego, California, 92103

United States

University of Florida

Gainesville, Florida, 32610

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Adva-Tec

Mitchell Humphreys, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-07-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

ureteral stent

Additional Relevant MeSH Terms

Ureteral Diseases