RecruitingNAINTERVENTIONAL

Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer

Doctors are running a study to check how well a new device, called Nevisense, can help identify a common type of skin cancer. This type of cancer is known as keratinocyte skin cancer, and it includes things like basal cell carcinoma, squamous cell carcinoma, and Bowen's disease. If a doctor suspects you might have this kind of skin cancer and plans to remove the suspicious skin, you might be able to take part. The study will use the Nevisense device to see if it can accurately spot these skin cancers before they are removed for closer inspection. The main aim is to understand if this device can be a useful tool for doctors when checking for skin cancer.

At a glance

Status

Recruiting

Phase

Sponsor

SciBase AB

Enrolment target

150

Start

13 Jul 2023

Estimated completion

01 Feb 2025

Keratinocyte Skin Cancer

What is this study about?

Imagine your doctor spots a patch of skin that looks a bit unusual, and they're wondering if it could be a common type of skin cancer called keratinocyte skin cancer. This study is testing a new device, called Nevisense, specifically designed to help doctors get a clearer picture of these suspicious spots.

Keratinocyte skin cancers are very common, and include things like basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Bowen's disease (BD), and actinic keratosis (AK). Currently, if a doctor is concerned, they usually suggest removing a small piece of the skin (a biopsy) or the whole spot, to send it to a lab for checking. This study wants to see if Nevisense can provide helpful information before that step.

The Nevisense device uses a special technology to look at the skin spot. The study will compare the information from Nevisense with the results from the lab after the skin is removed. By doing this, researchers can find out how accurate and helpful Nevisense is in identifying these skin cancers. This could potentially help doctors make decisions about suspicious skin areas in the future.

Key takeaways

The study tests a device called Nevisense for common skin cancers.
It aims to help doctors identify suspicious skin spots more effectively.
Participation involves using the device on a spot your doctor already plans to remove.
There are no special medications or extra follow-up visits for the study.
You can withdraw from the study at any time.

Who may be eligible?

You might be able to join this study if you are 18 years or older, male or female, and your doctor thinks you might have a common type of skin cancer (like basal cell carcinoma, squamous cell carcinoma, Bowen's disease, or actinic keratosis) and they are planning to remove the suspicious skin or take a sample.

However, there are certain situations where you wouldn't be able to join. For example, if the suspicious skin spot has already spread to other areas, or if it's on your hands, feet, genitals, or in areas that are scarred, scabby, or covered in thick hair. You also can't join if the spot has been treated before, or if it's on a mucous surface like inside your mouth. If the skin is severely sunburnt or has tattoos or splinters, or if it's in a place that's hard to reach for the device (like inside your ear), you wouldn't be suitable either.

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?
Does your doctor suspect you might have a common type of skin cancer?
Is your doctor already planning to remove or biopsy the suspicious skin spot?
Is the suspicious spot NOT on your hands, feet, genitals, or in a scarred/hairy area?
Has the suspicious spot NOT been treated or biopsied before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would be quite simple. The Nevisense device would be used on the suspicious skin spot that your doctor is already planning to remove or biopsy. This is usually a quick and painless process. You wouldn't need to take any special medication for the study, and your doctor will proceed with removing the skin spot as they normally would. There are no additional follow-up visits specifically for the study beyond what your doctor would normally recommend. The whole process related to the study itself would likely happen during one visit to your doctor.

Potential risks and benefits

Taking part in this study could have some benefits for you, as it might help researchers develop better ways to identify skin cancer in the future. There are no direct medical benefits to you personally from using the Nevisense device in this study, as your doctor's plan for your care will remain the same. The risks are very low; the Nevisense device is applied to the surface of the skin and is generally considered safe. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CentroDerm
Verified postcode
Wuppertal, Germany· Recruiting

Common questions

What is keratinocyte skin cancer?

It's a common type of skin cancer, including basal cell carcinoma, squamous cell carcinoma, and Bowen's disease.

What is Nevisense?

It's a device being tested to help doctors identify suspicious skin spots that might be skin cancer.

Will Nevisense replace my doctor's decision?

No, it's a tool to help your doctor. Your doctor will still make decisions about your care.

Is using Nevisense painful?

It's applied to the skin surface and is generally not painful.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without affecting your medical care.

How to find out more

Per Svedenhag

per.svedenhag@scibase.com +46 8410 620 01 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.