Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy (URIPRENE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04565795|
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : May 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ureteral Diseases||Device: Uriprene® Degradable Temporary Ureteral Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments post-uncomplicated ureteroscopy (UURS).|
|Masking:||None (Open Label)|
|Official Title:||URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy|
|Actual Study Start Date :||August 1, 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||February 2023|
Experimental: Placement of ureteral stent post ureteroscopy
Subjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS)
Device: Uriprene® Degradable Temporary Ureteral Stent
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.
- Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours [ Time Frame: 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.
- Primary Safety Endpoint defined as assessment of adverse events through 90 days [ Time Frame: 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
- Overall Clinical Success [ Time Frame: 90 days ]Adequate urine drainage with no intervention and no definitely device-related serious adverse events (SAEs) throughout the 90-day follow-up period.
- Technical success of the device [ Time Frame: 90 days ]Complete degradation/elimination of the stent from the urinary system within 90 days as measured by radiological assessment.
- Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications. [ Time Frame: 90 days ]Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565795
|Contact: Jennifer Cartledge, MS||(864) email@example.com|
|Contact: Roberta Hines, BS||(425) firstname.lastname@example.org|
|United States, Arizona|
|Mayo Clinic Arizona||Not yet recruiting|
|Phoenix, Arizona, United States, 85054|
|Contact: Mitch Humphreys, MD 480-342-2793 email@example.com|
|United States, California|
|University of California Los Angeles||Recruiting|
|Los Angeles, California, United States, 90404|
|Contact: Matthew Dunn, MD 424-259-7909 MDDunn@mednet.ucla.edu|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Manoj Monga, MD 619-543-7830 firstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Bodo Knudsen, MD 614-293-8155 email@example.com|
|Principal Investigator:||Mitchell Humphreys, MD||Mayo Clinic|