RecruitingNot ApplicableNCT06815120

A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent

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


Sponsor

University of Southampton

Enrollment

50 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Urological stents and catheters often lead to inflammation, causing pain and infection in the urinary tract. Moreover, 80% of stents are associated with pain, negatively impacting on QoL and mental health. Offering novel designs with significantly lower E\&B leads to a reduction in UTIs and improves QoL. Reducing hospital admissions (from 3 to 1 per patient, annually) would free \>100,000 bed-nights, allowing the elderly to regain independence. Our proposed research could have a significant impact towards fulfilling the 'healthy-ageing' Grand Challenge. Additionally, the novel stent reduces prevalence of infections and therefore, of antibiotic prescriptions contributing to the Global AMR challenge.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Experimental ureteric stent with specially shaped side-holes that prevent stagnation points (i.e., areas of low flow that cause particles to settle and E&B) and Qualitative interview for people with catheter blockage, kidney stone, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExperimental ureteric stent with specially shaped side-holes that prevent stagnation points (i.e., areas of low flow that cause particles to settle and E&B)

Kidney stone patients and Oncology patients admitted to either the University Hospital Southampton (UHS) or University College London Hospital (UCLH) for management of kidney stones or for the management of urine drainage in ureter will have a novel ureteric stent instead of their planned conventional stent. The novel stent will be removed after 4 weeks (kidney stone patients) or 25 weeks (oncology patients). Recruitment to the cohort of oncology patients will only commence once the results for kidney stones patients have been reviewed.

OTHERQualitative interview

Kidney stone patients, Oncology patients and doctors will be interviewed about their experience of having a stent, or their experience in managing patients with a stent.


Locations(2)

University Hospital Southampton

Southampton, England, United Kingdom

University College Hospital London

London, London, United Kingdom

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NCT06815120


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