LOF-0039 New LoFric Male and Female Pre-Market V1.0
Research type
Research Study
Full title
An open, non-controlled, interventional, multicenter, pre-market clinical investigation to evaluate the clinical safety and performance of a hydrophilic intermittent urinary catheter (New LoFric Male and New LoFric Female) in adult male and female patients
IRAS ID
354556
Contact name
Peter Taffo
Contact email
Sponsor organisation
Wellspect HealthCare
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
This study will be conducted to evaluate the safety and clinical performance of two new urinary catheters for intermittent catheterisation in female and male adults, New LoFric Female and New LoFric Male.
These new catheters are improved versions of existing catheters, LoFric Elle and LoFric Origo. The main improvement is the presence of a larger number of eyelets to enable complete urine drainage without any need for repositioning during the procedure. These are sterile, single-use, pre-lubricated catheters that are intended to be used at home or in healthcare settings. Two different sizes of each catheter will be evaluated in the study (CH12 and CH14).
The study population will include adult (≥18 years) male and female subjects who suffer from bladder voiding dysfunctions and who are experienced in intermittent catheterization. The study will comprise two visits to the clinic that will be 14 days (± 3 days) apart.
Approximately 55 participants will be enrolled in this study at 3-4 sites in Europe, initially in the United Kingdom and in Germany. The primary objective is to evaluate the performance of the new devices, and more specifically, whether complete bladder emptying is achieved with no need to reposition the catheter during the procedure. In addition, secondary objectives will be to evaluate i) the subjects’ overall satisfaction and perception of the treatments with the devices, ii) the incidence of urethral trauma, strictures, and hematuria/bleeding and iii) the ability of sediments and particles to pass through the catheter eyelets.
With a planned recruitment period of 7.5 months, the total duration of the clinical investigation is estimated to be approximately 8 months.REC name
London - Stanmore Research Ethics Committee
REC reference
25/LO/0259
Date of REC Opinion
28 May 2025
REC opinion
Further Information Favourable Opinion