frequently asked questions

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Q1
  • What is the purpose of a clinical trial?

Clinical trials are research studies that doctors conduct with the participation of qualified volunteers. Clinical trials are designed to find out about the safety and effectiveness of possible new medications, medical devices, and medical procedures.



Q2
  • How is the ReShape Duo designed to work?

The ReShape Duo is a silicone dual-balloon system that is placed in the stomach during a 30-minute outpatient procedure. The balloons do not change the stomach’s natural anatomy; they simply occupy space to reduce the capacity for food. The ReShape Duo remains in the stomach for six months, serving as built-in portion control while trial subjects learn to live a healthier lifestyle with the support of dietitians, doctors, and nurses.



Q3
  • How much weight loss can be expected with the ReShape Duo?

The amount of weight a subject can expect to lose during the REDUCE Clinical Trial depends on several factors, including level of dedication to living a healthier lifestyle including diet and exercise. Recent trials involving the ReShape Duo system have shown patients lose, on average, one-third of their excess weight in 6 months.



Q4
  • Can I receive the ReShape Duo without joining the REDUCE Clinical Trial?

No, the ReShape Duo is an investigational device and is currently only available in the United States through the REDUCE Clinical Trial.



Q5
  • Are there any costs involved in the REDUCE Clinical Trial?

If you qualify and choose to join the REDUCE Clinical Trial, you will receive study-related care at no cost. This includes the ReShape Duo Balloon System, as well as a comprehensive weight loss support program overseen by a team of dietitians, doctors, and nurses. You may also be compensated for your time and travel.



Q6
  • How long will the REDUCE Trial last?

The study will last about 8 months. During this time, you will visit your study doctor’s office approximately once per month to receive diet and exercise counseling at no cost, and to provide feedback about your experiences. These visits are an important part of the study, and are designed to keep you on track with your customized weight loss program.



Q7
  • Does my Body Mass Index (BMI) qualify for the REDUCE Clinical Trial?

If your BMI is between 30 and 40, you may be eligible for the REDUCE Clinical Trial. To estimate your BMI, please use the following BMI Calculator.



Q8
  • Who is the company sponsoring the REDUCE Clinical Trial?

The REDUCE Trial is being sponsored by ReShape Medical, Inc., a medical device company headquartered in San Clemente, CA (www.reshapemedical.com).



Q9
  • I am interested in hearing more. What is the next step?

To get connected with the local REDUCE study center in your area, the next step is to take the pre-screening questionnaire. The questionnaire will help determine if you meet some of the main criteria for the study. If the pre-screening questionnaire indicates you qualify, you will be given the option to have your contact information sent directly to the local REDUCE study center in your area. Someone from your local study center will then contact you within a couple of days to tell you more about the study, and help you decide whether you would like to participate. Please click here to find out how to take the pre-screening questionnaire.