Right now, doctors in the U.S. are conducting the Essential Trial™. This research study is evaluating the
POSE procedure, an investigational, minimally-invasive weight-loss procedure that does not
involve any skin incisions or scars. The trial also includes a comprehensive weight-loss support
program overseen by a study team of nutritionists, doctors, and nurses.
• West Columbia, SC
• Miami, FL
If you qualify and choose to join the Essential Trial, you will receive study-related care at no cost. This includes the
POSE procedure, as well as a comprehensive weight-loss support program. You may also be compensated for your
time and travel.
As part of the Essential Trial, 2 out of every 3 participants will initially undergo the POSE procedure, while 1 out of every 3 participants will undergo a simulated or “control” procedure. The control procedure is nearly identical to the POSE procedure, except in the control procedure the stomach tissue is not folded and sutured. If you choose to join the trial, you will be randomly assigned (like pulling numbers from a hat) to initially undergo the POSE procedure or the control procedure. You will not be told which procedure you have undergone until your 12-month follow-up visit. At that time, if you had originally received the control procedure and still meet the study criteria, you may be offered the opportunity to undergo the POSE procedure at no cost, and your study physician will continue to track your progress.
Regardless of whether you initially receive the POSE procedure, or if you receive it after your 12-month visit, your participation in the study will last about 2 years. During this period, you will visit your study doctor’s office at regular intervals to receive diet and exercise counseling at no cost, while also providing feedback about your experiences.
These visits are an important part of the study, and are designed to keep you on track with your personalized weight-loss program.