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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
Sponsor:
Collaborator:
Northwest Clinical Research Group
Information provided by (Responsible Party):
Adva-Tec

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

Condition or disease Intervention/treatment Phase
Ureteral Diseases Device: Uriprene® Degradable Temporary Ureteral Stent Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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 Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.
  4. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Cartledge, MS (864) 506-0097 jcartledge@adva-tec.com
Contact: Roberta Hines, BS (425) 766-0308 rhines@nwcrg.com

Locations
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United States, Arizona
Mayo Clinic Arizona Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Mitch Humphreys, MD    480-342-2793    humphreys.mitchell@mayo.edu   
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    mamonga@health.ucsd.edu   
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Bodo Knudsen, MD    614-293-8155    bodo.knudsen@osumc.edu   
Sponsors and Collaborators
Adva-Tec
Northwest Clinical Research Group
Investigators
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Principal Investigator: Mitchell Humphreys, MD Mayo Clinic
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Responsible Party: Adva-Tec
ClinicalTrials.gov Identifier: NCT04565795    
Other Study ID Numbers: CLN 0001
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Adva-Tec:
ureteral stent
Additional relevant MeSH terms:
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Ureteral Diseases
Urologic Diseases