Design frozen and on track for 'First in human' clinical trials

We are delighted to have reached some important milestones;

  • Design freeze; After several months of intensive further development we have frozen the design that will now be taken forward to the ‘first in human’ clinical trials. Key to this was further development of the chosen balloon material, the profile of the catheter tip, the bonding adhesives and the lubricious coating, working closely with our technology partners in each area. This now clears the way for us to make up the close to 300 devices that will be sent for the full range of independent testing needed to seek the necessary approvals for the trials.

  • Grant funding for ‘first in human’ clinical trials; Grant funding has been secured for the trials that are due to commence in Q2 2019 (subject to the above approvals). They will be run in two centres, the Bristol Urological Institute (BUI)/ Southmead Hospital and University Hospital Southampton under the direction of Prof. Marcus Drake and Prof. Mandy Fader.

On Friday 9th November, we were also delighted to be a part of the BUI’s Annual Scientific Meeting when Dr. Nicola Morris made a presentation on the Flume Catheter as part of session in recognition of the legacy of Prof Roger Feneley.

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Results of Survey of Nurses caring for Catheter Patients

We wanted to share the results of our survey completed by nurses caring for catheter patients.  Firstly, a huge thank you; we had responses from over 150 nurses caring for over 2,500 catheter patients. More than simply hard numbers you have shared your experience of the reality of patients' care. Thanks also to the Nursing Times and their article and link to the survey, as the numbers really climbed in the days after that feature.

What have we learned?  It has certainly confirmed the scale of the problems experienced; on average, close to 40% of catheters are found to block within 4 weeks, nearly 2/3 within 6 weeks and at least 90% within three months. Close to 50% of patients  suffer bypassing and a similar level have needed antibiotics for CAUTI’s.  We do though, see quite a variation in the levels reported, perhaps reflecting different local practices or patient characteristics?  What is consistent is the concern expressed in the many examples you have given and the questions posed of us.  Some of the themes that we have taken from this include;

·      Suprapubic; many of you are concerned about supra-pubic catheters.  The design of the Flume should be just as relevant for suprapubic as urethral use and we will ensure that we get approvals for both routes.

·      Bypassing; While CAUTI’s and blockage are clearly a problem, bypassing appears to get typically less coverage and your scores and comments reinforce its significance as a concern for patients and carers.  As a GP I had not realised just how big an issue it clearly is, so it is great that the Nursing Survey has brought this into sharp focus. We believe that the Flume design should have significant benefits here due to reduced encrustation and no exposed tip to be bent over, occluding the drainage eyes and thereby causing bypassing. At the same time we anticipate greatly reduced bladder spasms which are another primary cause. This is because the Flume is anticipated to irritate the bladder much less. It has half the device length internally than the Foley and it has a soft protective balloon over the tip quite different to the exposed Foley tip. We hope to be able to prove this in the proposed clinical trials and monitoring of patient quality of life measures

·      Traumatic removal;  A number of you highlighted the trauma caused when the catheter balloon is forcibly removed still inflated, perhaps by a patient with Alzheimers or with an accident snagging an insufficiently secured urine bag.  This is very timely as we finalise the patient ready specification of the Flume.

The survey feedback has been invaluable as we finalise the design and prepare for ‘first in human’ clinical trials, that we hope to start early next year.  More news in due course, not least as we hope to announce good news on the associated grant application.  

John

Nursing Times article

With huge thanks to Nursing Times for their comprehensive online article on Flume.  We are particularly keen to get the best possible input from nurses caring for patients with catheters and the article has created a great level of inbound interest and feedback.  We were the most popular story when featured as a daily headline (!) and are now listed under News - Research and Innovation

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