Other study requirements will apply. If you choose to participate, the study doctors will provide more information. Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
About the ReCET Procedure
What is the ReCET Procedure?
The ReCET Procedure is a non-surgical, investigational treatment designed to improve blood sugar control in adults with Type 2 Diabetes. During the procedure, a doctor introduces a small camera through the mouth to place a specialized device (catheter) in the duodenum (the first part of the small intestine). The catheter then delivers highly controlled electrical pulses to the lining of the duodenum. The electrical pulses trigger the body’s natural process to regenerate healthy cells that can help control blood sugar levels. The camera and catheter are then removed, and nothing is left inside the body.
Following routine observation, the patient can return home the same day and resume normal activities shortly after.
What does “investigational” mean in research?
Investigational means the ReCET System can only be used in clinical research studies. Use outside these studies is not approved by regulatory authorities like the U.S. Food and Drug Administration (FDA) or Therapeutic Goods Administration (TGA) in Australia.
Type 2 Diabetes (T2D) currently impacts over 400 million people worldwide. People with Type 2 Diabetes can have difficulty managing their blood sugar levels. This can be damaging to the body and cause other serious health issues.
Living with Type 2 Diabetes can be challenging. The ReCET™ Procedure being offered in this study is designed to reset body’s natural mechanism for regulating blood sugar levels and may help get your diabetes under control.
If you are interested in learning more about ReCET or want to see if you qualify to participate in the ReCET Study, take this brief pre-screening questionnaire.
Here are some common questions and answers about study participation.
What does study participation involve?
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine or therapy, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study. Participation in clinical research studies is your choice, and you may stop at any time.
Will there be a cost to participate in the study?
There is no cost to participants for care provided as part of the study. A stipend (or reimbursement) for study-related expenses will also be provided.
What does informed consent mean?
Before participating in a research project, you will receive an informed consent document in your native language. This contains the necessary information about the research project, so you will know the process of the research project and what is expected of you. This means that you will have to go over the informed consent document before you decide whether you want to participate in the study or not, so that you will feel comfortable with the process.
Am I able to leave the research project after it has begun?
Yes, you are always able to leave the research project, even though it has begun. You are not committed in any way and have not signed any contract to participate. You do not have to provide us with a reason as to why you wish to quit the research project. However, the researchers might benefit from this information, as they might want to use your reason not to participate, for other research projects.
How is my safety taken care of?
When it comes to clinical studies, your safety as a participant is pivotal. Clinical studies are conducted according to the guideline of good clinical practice and the ethical principles, described in the Declaration of Helsinki II. The Declaration of Helsinki secures your right to e.g.: – Self-determination: If you do not wish to participate in the clinical study, you are able to leave at any point. – Informed decisions: At any point within the clinical study, you will have the right to make informed decisions, both at the beginning (informed consent) and during the clinical study. – Welfare of the participant: The welfare of the participant must always be prioritized above the interest of science and society. This means, that the clinical study must not prioritise the medical outcome highest.
Why participate in a research project?
Clinical studies are conducted to find new ways to treat diseases or even prevent or detect them. These treatments could be new medicine, surgical procedures, medical devices or a new way to use treatments that already exist.
