A phase Ib study to investigate the safety and effect of BR-003
This research is investigating a new treatment called BR-003. It's an early-stage study, meaning it's the very first time this treatment is being tried in people. The main goal is to check how safe BR-003 is and understand its effects in adults aged 18 and over. Participants in this study will be people who are already scheduled to have a specific type of back surgery. This surgery involves stabilising the spine with screws at the back, which might also include other common procedures like fusions or decompressions. It’s important to remember that this is a very early step in understanding BR-003, and studies like this help us learn if new treatments are promising enough to research further.
At a glance
What is this study about?
Imagine you're having an operation to help stabilise your spine, perhaps because of back problems. This study is looking at something new, called BR-003, that might be used alongside this type of surgery. It's like testing a new addition or helper for a known procedure.
This is a very early-stage study, often called a 'Phase I' study. Think of it as the first time a new treatment is introduced to people, almost like a first meeting. The main aim isn't to cure a condition, but to carefully check how safe the treatment is and to understand what it does inside the body. Doctors want to see if there are any unexpected effects or side effects.
By taking part, you would be helping medical science learn more about BR-003. This information is really important because it helps researchers decide if this new treatment is safe enough and shows enough promise to be studied more widely in the future. Every step in this kind of research is vital for potentially developing new and better ways to help people in the long run.
Key takeaways
- This is an early-stage study (Phase I) checking a new treatment called BR-003.
- The main goal is to find out if BR-003 is safe and what it does in healthy adults.
- You must be scheduled for a specific type of spinal surgery to be eligible.
- Participation helps advance medical research, potentially leading to new treatments.
- You will be closely monitored by a medical team if you take part.
- You can stop participating at any time without affecting your normal care.
Who may be eligible?
This study is looking for adults aged 18 years or older, with no upper age limit. Both men and women can take part.
You would be considered for this study if you are already scheduled to have a specific type of back surgery. This surgery involves stabilising the back part of your spine using special screws. This could be a 'posterior spinal stabilisation' procedure, whether it's done openly or with smaller cuts. Your surgeon would be using 4 or 6 screws that are between 5 and 7.5 millimetres wide.
It's important that your planned surgery fits these criteria. Your doctor can tell you if your specific procedure matches what they are looking for in this study. Even if your surgery also includes other common spinal procedures like fusions or decompressions, you might still be able to join.
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 scheduled for spinal surgery that uses 4 or 6 screws (5-7.5mm wide) in the back of your spine?
- Are you willing to have additional checks and follow-up visits related to the study?
- Have you discussed your planned surgery and this study with your doctor?
What does participation involve?
If you decide to take part, you would be receiving BR-003 alongside your planned spinal surgery. The researchers would carefully monitor you before, during, and after the surgery to understand how your body reacts to the treatment. This will involve a set number of visits to the clinic, which your study team will explain in detail. These visits usually include health checks, blood tests, and possibly scans. You will receive the study treatment, BR-003, as part of the study. The total time you'd be involved in the study, from your first visit to your last follow-up check, will be clearly explained by the study team before you make any decisions.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is BR-003?
BR-003 is a new treatment being studied for the first time in people, alongside certain types of spinal surgery.
Why is this study being done?
This study aims to check how safe BR-003 is and what effects it has in the human body, which is the first step in developing new treatments.
Do I have to pay to join the study?
No, you do not have to pay to participate in a clinical trial. Study-related medical care and the treatment are usually provided free of charge.
Will my regular spinal surgery be affected?
Your spinal surgery will proceed as planned, with BR-003 being an additional part of your care during the study. The study team will explain how this works.
What happens if I change my mind?
You are free to leave the study at any time, for any reason, without it affecting your medical care or relationship with your healthcare team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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