EU Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner.
This study is tracking how a new scanning device, the Histolog® Scanner, is used in hospitals and clinics. This scanner helps doctors look at body tissues during operations or medical procedures. Researchers want to understand how effective and safe this scanner is when used by different medical teams on various conditions, rather than in a controlled experiment. By observing its use in everyday medical practice, they hope to gather important information about its benefits and any potential drawbacks. This information will help ensure that the device is working as expected and improving patient care. It's an observational study, meaning patients won't be given any new treatments or asked to do anything differently besides their planned medical procedure.
At a glance
What is this study about?
Imagine doctors are performing an operation or a medical test. Sometimes, they need to quickly look at tiny details of body tissues to help guide them. The Histolog® Scanner is a special device designed to take very detailed pictures of these tissues right away, even while an operation is still happening. Instead of sending samples to a lab and waiting for days, this scanner can provide immediate images. This could potentially help doctors make quicker decisions during your procedure.
This study is not testing a new medicine or a complicated treatment. Instead, it's like watching how a new tool is used in a workshop. Doctors and researchers want to see how the Histolog® Scanner performs in various hospitals and clinics, with different patients and different health conditions. They are collecting information about how effective it is and if it has any safety concerns when used in day-to-day medical practice.
The main goal is to gather what's called 'real-world evidence.' This means they are taking notes and collecting information on patients who are already having a procedure where their doctor decides to use the Histolog® Scanner. This helps ensure the scanner is doing what it's supposed to do and is safe for patients in general use. The study is open to adults who are having a surgery or medical procedure where their medical team chooses to use the scanner.
Key takeaways
- The study looks at an imaging device called the Histolog® Scanner.
- It collects 'real-world' information on how the scanner performs and its safety.
- Participation means no extra tests or changes to your planned medical care.
- You must be an adult having a procedure where the scanner is already in use.
- This study helps improve understanding of medical technology for future patients.
Who may be eligible?
To be able to take part in this study, you must be at least 18 years old. You also need to be having an operation or another medical procedure where your healthcare team plans to use the Histolog® Scanner as part of your care. It's important that you can understand what the study involves and are willing to sign a form giving your permission to take part.
You would not be able to join this study if you are already taking part in another medical study that involves a new drug, device, or other procedure that hasn't finished yet. Also, if you are under special legal protection, for example, if a court has appointed someone to manage your affairs, you would not be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you having a surgery or medical test where your doctor will use the Histolog® Scanner?
- Can you understand the study information and give your permission?
- Are you NOT currently in another medical study that hasn't finished yet?
What does participation involve?
If you decide to take part in this study, you won't actually need to do anything extra or have any additional visits. Your participation will simply involve your hospital team collecting some information about how the Histolog® Scanner is used during your planned surgery or medical procedure, and how you get on afterwards. You won't be given any new medication specifically for the study, nor will you have any extra tests or follow-up appointments. The study simply observes the use of the scanner during your existing care. The total duration of your involvement will solely depend on the length of your medical procedure and the general collection of data by your medical team.
Potential risks and benefits
Locations (1)
- Royal Surrey County Hospital NHS Foundation TrustVerified postcodeGuildford, United Kingdom· Recruiting
Common questions
What is the Histolog® Scanner?
It's a special device used during operations or medical procedures to get quick pictures of body tissues, helping doctors make decisions on the spot.
Will I have extra tests or treatments if I join?
No, you won't have any extra tests, treatments, or medicines specifically for this study. It only observes your planned medical procedure.
Do I need to do anything differently?
You don't need to do anything differently. Your medical team will use the scanner as part of your planned care, and information will be collected about its use.
What kind of information will be collected?
Researchers will collect information about how the Histolog® Scanner is used during your procedure and how it performs, but no personal identifying details will be shared.
Can I leave the study if I change my mind?
Yes, you can decide to stop participating at any time without it affecting the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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