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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04565795
Other study ID # CLN 0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Adva-Tec
Contact Jennifer Cartledge, MS
Phone (864) 506-0097
Email jcartledge@adva-tec.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. The study is intended to assess the safety and efficacy of the Uriprene® Stent by assessing 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 87
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion 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. Exclusion Criteria: 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States The Ohio State University Columbus Ohio
United States University of California Los Angeles Los Angeles California
United States Mayo Clinic Arizona Phoenix Arizona
United States University of California San Diego San Diego California

Sponsors (2)

Lead Sponsor Collaborator
Adva-Tec Northwest Clinical Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Overall Clinical Success Adequate urine drainage with no intervention and no definitely device-related serious adverse events (SAEs) throughout the 90-day follow-up period. 90 days
Secondary Technical success of the device Complete degradation/elimination of the stent from the urinary system within 90 days as measured by radiological assessment. 90 days
Secondary Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications. Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications. 90 days
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