← Back to Search

Ureteral Stent

Degradable Ureteral Stent for Ureteral Disease (URIPRENE Trial)

N/A
Recruiting
Led By Mitchell Humphreys, MD
Research Sponsored by Adva-Tec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
Subjects who are >21, <80 years of age; inclusive of males and females.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

URIPRENE Trial Summary

This trial is testing a new type of degradable stent for safety and performance.

Who is the study for?
This trial is for adults aged 21-80 with unilateral ureteral or renal stones who've had a successful, uncomplicated ureteroscopy. They must be able to fit one of the specified stent sizes and not have urinary tract abnormalities, active infections, severe kidney dysfunction, or certain other medical conditions. Women must use reliable contraception.Check my eligibility
What is being tested?
The Uriprene® Degradable Temporary Ureteral Stent's safety and performance are being tested in this non-randomized study across multiple centers. The stent is designed for patients following an uncomplicated procedure to remove kidney stones.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort during insertion or removal of the stent, potential irritation while it's in place, urinary symptoms like frequency or urgency, and possible infection risk.

URIPRENE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a successful kidney stone removal surgery without complications.
Select...
I am between 21 and 80 years old.

URIPRENE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours
Primary Safety Endpoint defined as assessment of adverse events through 90 days
Secondary outcome measures
Overall Clinical Success
Technical success of the device
Pharmaceutical Preparations

URIPRENE Trial Design

1Treatment groups
Experimental Treatment
Group I: Placement of ureteral stent post ureteroscopyExperimental Treatment1 Intervention
Subjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS)

Find a Location

Who is running the clinical trial?

Northwest Clinical Research GroupUNKNOWN
Adva-TecLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Mitchell Humphreys, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
178 Total Patients Enrolled

Media Library

Uriprene® Degradable Temporary Ureteral Stent (Ureteral Stent) Clinical Trial Eligibility Overview. Trial Name: NCT04565795 — N/A
Ureteral Disease Research Study Groups: Placement of ureteral stent post ureteroscopy
Ureteral Disease Clinical Trial 2023: Uriprene® Degradable Temporary Ureteral Stent Highlights & Side Effects. Trial Name: NCT04565795 — N/A
Uriprene® Degradable Temporary Ureteral Stent (Ureteral Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04565795 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants younger than 65 years eligible for this research?

"To be eligible for this trial, participants must be 21 years or older, but not exceed 80."

Answered by AI

Are there still opportunities to enroll in this research endeavor?

"According to clinicaltrials.gov, this research project is actively seeking participants. The protocol was initially published on the 1st of August 2021 and underwent its last amendment on May 24th 2022."

Answered by AI

Are there multiple venues in the United States where this clinical trial is being conducted?

"This research is taking place at 4 different sites, such as University of California Los Angeles in Los Angeles, Mayo Clinic Arizona situated in Phoenix and The Ohio State University located in Columbus."

Answered by AI

How many enrollees are accepted into this research experiment?

"To complete the trial, 87 participants who meet the predetermined criteria are necessary. People can sign up for this clinical experiment from various locations such as University of California Los Angeles in Los Angeles, Arizona and Mayo Clinic Arizona in Phoenix, Ohio."

Answered by AI

What criteria must be met for individuals to qualify as participants in this medical study?

"To be admitted to the trial, applicants must possess a ureteral disorder and fit within the age range of 21 - 80. Currently there are 87 spots open for prospective participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
2022. "Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04565795.
~17 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top