New shaped ureteric stent for people with kidney stones or cancer-related ureter blockage compared with a conventional JJ stent
Official title: Two Single Arm, Multicentre Unblinded First-in-human Trials Investigating a Novel Ureteric Stent to Determine the Reduction of Encrustation, Biofilm Deposition and Complications Compared to a Conventional JJ Stent
Run by University of Southampton · NCT06815120 · Data updated 2026-11-12
This tests a new ureteric stent with specially shaped side-holes to see if adults needing stents for kidney stones or cancer have less blockage, infection, pain, and antibiotic use.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Southampton Academic / other |
| Locations | 2 sites (Southampton, England and 1 other locations) |
| Status | Recruiting |
| Started | August 6, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT06815120 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who need a ureteric stent for kidney stones or for ureteral compression from abdominal/pelvic cancer, have prior stent experience, are awaiting insertion or replacement, and can give informed consent and complete study paperwork in English.
✕Probably not a fit
People expected to survive less than four months, those unfit for stent insertion, pregnant people, or those unable to comply with study procedures are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who require ureteric stents for kidney stones or ureter compression from pelvic/abdominal cancer will receive either a novel stent with specially shaped side-holes or a conventional JJ stent at participating NHS centres. The design aims to reduce low-flow stagnation points that promote particle deposition, encrustation and biofilm formation, and outcomes will include device encrustation/biofilm, urinary tract infection rates, pain, antibiotic prescriptions, hospital admissions and quality of life measures. Participants will also take part in qualitative interviews about symptoms and device experience. The intervention is delivered at specialist urology centres with clinical follow-up after insertion and stent replacement as required.
Why it matters
Potential benefit: If successful, the novel stent could lower stent blockage and infections, reduce antibiotic use and hospital admissions, and improve patients' pain levels and quality of life.
How similar studies have gone: Early device and preclinical work suggests reduced particle deposition and encrustation with this design, but randomized clinical comparisons versus conventional JJ stents are limited, making this approach relatively novel in practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 years or over 2. Ureteric stents clinically indicated either due to kidney stones or abdominal/pelvic cancers compressing ureters 3. Previous experience with ureteric stents 4. Awaiting insersion/replacement of stents 5. Ability to give consent 6. Ability to interact with study documentation 7. Sufficient English to complete study documentations and questionnaires Exclusion Criteria: 1. Expected survival \<4months 2. Unfit for stent insertion 3. Unable to comply with study processes Pregnancy
Where it's running
-
University Hospital Southampton
Southampton, England, United Kingdom Recruiting -
University College Hospital London
London, London, United Kingdom Recruiting
Study contacts
- Principal investigator: Ali Mosayyebi — University of Southampton
- Study coordinator: Ali Mosayyebi
- Email: a.mosayyebi@soton.ac.uk
- Phone: 02380594767
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.