Frequently Asked Questions

We’re sure you’ll have questions as you begin thinking about this. Here’s some help in answering them.

Where is the clinical study being conducted?

Dalton, GA
Orange County, CA
Portland, OR

What is the investigational device being studied?

The ReShape Dual-Balloon is the first and only investigational non-surgical dual balloon device for weight loss. The study device is placed in the stomach during a 15-minute outpatient procedure using only deep conscious sedation. After the balloons are placed in the stomach, it takes only a few days to adjust to the reduced-portion capacity before returning to normal activities. The ReShape Balloons do not restrict the kinds of foods you can eat – just the quantity, so you feel fuller faster. The ReShape Balloons remain in place for six months and are then removed. ReShape Balloons do not change or alter the natural anatomy of your stomach in any way; they simply occupy existing space to reduce its capacity for food.

Is the investigational device safe?

The ReShape Balloons Clinical Research Study is being conducted to determine the safety and effectiveness of the investigational ReShape Dual-Balloon. One of the purposes of the study is to determine the risks that may be associated with using the study device. Based on information from studies outside of the United States, the study device has been approved for clinical use as a weight loss treatment in other countries.

How long does the clinical study last?

Participants in the clinical study will be followed for one year. There are 22 visits over 48 weeks following the procedure. Participants are required to attend all visits over this one year clinical study.

How does the clinical study work?

All candidates need to meet eligibility criteria to participate in the ReShape Balloons Clinical Research Study. The study is randomized (like flipping a coin) which means there is a study balloon group and a control group. For every three participants, two participants will be in the study balloon group and one participant will be in the control group.

Participants in the control group will be placed on a structured diet and exercise program only and attend 22 visits over the 48 week period.

Participants in the study balloon group will receive the study device and will also be placed on a structured diet and exercise program and attend 22 visits over the 48 week period. Study balloon group participants will have the study device in their stomachs for six months, it will then be removed, and they will continue to be followed for six months after removal.

Why would I agree to be part of the control group?

A control group participant has the opportunity to follow a medically supervised diet and to receive behavioral counseling free of charge.

In addition, once the control group participant completes all 22 follow-up visits over the 48 week period, he or she will have the option to receive the investigational ReShape Balloons free of charge if he or she still meets the clinical criteria.

How much weight will I lose?

The ReShape Balloons Clinical Research Study is being conducted to determine the safety and effectiveness of the investigational ReShape Dual-Balloon. One of the purposes of the study is to determine the amount of weight loss that may result from the use of the study device. In recent studies outside of the United States, participants have lost up to 40 to 60 pounds in six months.*

What does it cost to participate?

Participation in this clinical study is on a volunteer basis. There is no cost obligation for participation in this study. All costs related to the clinical study are covered; any other medical expenses fall under your current health insurance (e.g., annual check-ups).

Can women who are pregnant or nursing participate in the clinical study?

No. Women who are nursing, pregnant or planning a pregnancy should not participate in the clinical study because the risks to the infant or fetus for study procedures are unknown.

Caution: Investigational device. Limited by Federal law to investigational use.

*Information from recent European Clinical Studies.

What have you got to lose?
Click here to find out if you may be a candidate.