Join our innovative clinical trial evaluating an investigational device, the RESET System, that is being researched to potentially improve blood sugar levels and increase weight loss in those with uncontrolled type 2 diabetes and obesity.
Those who qualify and choose to participate may be compensated up to $2,800 for up to 18 in-clinic visits and 7 phone visits over approximately 21 months.
This study is evaluating the safety and effectiveness of the RESET System to improve blood sugar levels and increase weight loss in those with uncontrolled type 2 diabetes and obesity. The RESET System consists of a RESET Delivery System, a RESET Liner, and a RESET Retrieval System. Using the RESET Delivery System, the RESET Liner is endoscopically (using a thin, flexible tube with a camera and light) implanted in the small intestine. The liner is open on both ends, so partially digested food can still move through the intestine, but it creates a barrier between the food and the intestine. By keeping food from directly touching this area, the device is thought to change the release of certain gut hormones and how the body responds to food. This is an “investigational” system because it has not been approved by the Food and Drug Administration (FDA).
If you qualify and choose to participate, there is a 75% chance you will receive the RESET System, and a 25% chance of receiving a sham procedure. A sham procedure is an inactive procedure that mimics the actual procedure, but the device will not be implanted.
After the screening visit and baseline visit, you will be in this study for approximately 21 months, which will include a 9-month treatment period (when the liner is implanted), and a 12-month follow-up period. The study will require up to 18 in-clinic visits and 7 phone visits. If you qualify and choose to participate, you may be compensated up to $2,800 for your study-related time and travel. Your participation is entirely voluntary, and you can leave the study at any time.
Those who qualify and choose to participate could receive:
Access to the study system and procedure at no cost
Access to lifestyle and nutritional counseling at no cost
Access to our top-tier study team of board-certified physicians at no cost
Compensation of up to $2,800 for 18 in-clinic visits and 7 phone visits over approximately 21 months
A research study or clinical trial is the process a potential new drug, device, procedure, or process goes through to evaluate if it is safe, tolerable and effective for the condition it is being studied for. Research studies are the only way to advance medicine for future generations.
Each study has its own set of inclusion and exclusion criteria that a participant must meet before they are allowed to participate in a study. Patients from all backgrounds and walks of life are encouraged to participate.
Every participant in every research study must go through the informed consent process. During this, the trial doctor and research team go over what will happen in the study, what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the study. Participants may withdraw their consent and discontinue the study at any time for any reason.
A sham control is an inactive procedure that mimics an actual medical procedure. Researchers use a sham control to help make sure any changes in the participants’ health are actually caused by the study procedure. You do not get to choose if you get the study treatment or the sham control, and you may not know if you get the sham control until after the study.
If studies do not include diverse participants, we cannot know if treatments work for everyone who needs them. Studies only tell researchers how something works for the participants of that study, and they may not work the same in people of different races, ethnicities, ages, or sexes.
All research studies must follow federal laws and ethical guidelines, including HIPAA. Studies must also be approved by an expert group called an institutional review board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.