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Tests treatment safety and results for Ureteral Diseases
Official title Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
ClinicalTrials.gov ID: NCT04565795
What this study is testing
- What it's testing
- A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- people who are \>21, \<80 years of age; inclusive of males and females.
- people with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
- people with asymptomatic, contralateral renal stones in sizes \<4mm WHICH ARE NOT IN THE RENAL PELVIS OR URETER and who have had uncomplicated...
- people 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.
- people with the ability to understand the requirements of the study, who have provided written informed consent, and are willing to undergo all...
You likely can't join if
- people 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.
See the full eligibility criteria
- people who are \>21, \<80 years of age; inclusive of males and females.
- people with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
- people 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...
- people 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.
- people 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.
- people 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.
- people with known/diagnosed overactive bladder (OAB).
- people with known/diagnosed urge urinary incontinence (UUI).
- people with a known, active upper or lower urinary tract infection at the time of stent insertion.
- people 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...
- Impacted ureteral stones still in place and/or incomplete stone fragmentation.
- Ureteral perforation.
- Staghorn calculi.
- people with a solitary kidney.
- History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed).
- Contrast allergy that cannot be adequately pre-treated.
- 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.
- Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.
- Subject has a known significant concomitant illness with a life expectancy of \<1 year.
- Subject is known to be currently enrolled in another investigational trial.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Gainesville, Florida, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Gainesville, Florida, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.