EMPOWER Clinical Trial: Vagal Blocking for Obesity Control - Stanford Hospital & Clinics

EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

You have the power to change.

If you are committed to losing weight, find out if participation in the EMPOWER clinical research study may help.

Change starts with commitment.

Losing weight isn’t easy. Neither is living with the extra weight that may be holding you back and harming your health. But even though you need to make a commitment to losing weight, it doesn’t mean you have to go it alone.

If you’ve considered gastric bypass or laparoscopic banding, but decided they weren’t right for you, there may be another option.

Could VBLOC™ Therapy be for you?

Unlike other types of bariatric surgery that alter the stomach’s anatomy, VBLOC Therapy is delivered by an implantable, investigational device intended to block signals carried on the vagus nerve between the brain and the digestive system that control sensations of hunger, satisfaction and fullness.

VBLOC Therapy includes both external and implanted components. It may also be turned off and is designed to be reversible, programmable and non-invasively adjustable.

By being able to reversibly control these signals, VBLOC Therapy may aid in weight loss.

The EMPOWER clinical research study.

This clinical research study is being conducted to evaluate the safety and effectiveness of VBLOC Therapy. If selected to participate in the study, you will receive implantation of the investigational device and participate in a medical weight management program. This program will provide education and advice on diet, exercise and behavior modification to assist you in meeting your weight loss goals.

Are you eligible to participate?

As with all clinical research studies, participation in the EMPOWER research study requires that you meet criteria that are determined by the study protocol. These criteria include:

• Males and females between the ages of 18 and 65
• Have a BMI (Body Mass Index) between 35 and 45*
• Sign an informed consent

These are not the only criteria for acceptance into the EMPOWER clinical research study. Only a clinical research staff member can make that determination.

* Participants with a BMI of less than 40 must have at least one co-morbid condition, such as Type 2 diabetes mellitus (at selected sites only), hypertension, high cholesterol, obesity-related cardiomyopathy or sleep apnea syndrome.

There is more to you. There is more to know.

If you’re ready to make a commitment to losing weight, you probably have more questions about VBLOC Therapy and the EMPOWER clinical research study. You can find out more by visiting www.EMPOWERstudy.com, or by calling the nurse-staffed information line at 1(866)356-3506, Monday – Thursday, 7:00am to 7:00pm and Friday, 7:00am to 6:00pm, CST.

Find out if VBLOC Therapy might be for you.

The EMPOWER clinical research study is being conducted at selected Centers of Excellence.

Approximately 21 subjects will be enrolled at Stanford. The total number of subjects enrolled across sites is 300.

Study sponsor EnteroMedics™

Contact Information

For more information on eligibility criteria and study details contact or visit http://med.stanford.edu/clinicaltrials/detail.do?studyId=1025

Marilyn Florero
(650) 724-1953
florerom@stanford.edu