Overview of The TOGA System
The TOGA® System from Satiety, Inc. was once touted as a promising new treatment for obesity. It was designed to be less invasive than other bariatric procedures and aimed to eliminate many of the problems associated with other bariatric surgeries.
The procedure was performed endoscopically and did not require surgical incisions or a medical implant. The purpose of treatment was to help individuals lose weight by reducing the size of the stomach to give a sense of fullness after a small meal.
Clinical trials began in 2008 and preliminary information reported positive short-term results. In late 2010, the prestigious Cleveland Clinic named the "scar-less" weight loss surgery as one of the Top 10 Medical Innovations for 2011.
All the promise of what the procedure could offer, however, went away when the results of the clinical trial came in showing that patients lost far fewer pounds than the company had hoped. Venture capitalists who had invested $86 million in Satiety over a decade shut the company down.
At this time, further research and development has been put on hold and the TOGA® procedure is not yet approved by FDA.
The TOGA® information that follows was written while clinical trials were still ongoing and has been left up for historical reference.
The TOGA® System is an experimental new treatment for obesity that is designed to be less invasive than other bariatric procedures. The procedure does not require surgical incisions or a medical implant and aims to eliminate many of the problems associated with current bariatric surgeries. The purpose of treatment is to help individuals lose weight by reducing the size of the stomach to give a sense of fullness after a small meal.
The TOGA® System is not yet available for widespread use, but is currently the focus of a multi-center study in the United States for the purpose of gaining FDA approval.
The company behind the TOGA® System is Satiety, Inc., a medical device company that is developing technologies to provide obese patients with less invasive treatment options.
- TOGA® System: named for transoral gastroplasty, or translated "stomach surgery through the mouth"
With this system, the procedure is performed endoscopically (through the mouth) and therefore considered "non-surgical" as it does not involve either conventional open surgery or laparoscopic surgery. A set of flexible devices is inserted through the mouth into the stomach in order to staple together sections of the stomach and thus reduce it's overall food capacity.
The procedure can be performed by bariatric surgeons, general endoscopic surgeons, and gastroenterologists who have been properly trained to use the TOGA® System.
The Method - Stomach Stapling Without Surgery
The TOGA® System is a set of flexible stapling devices that is inserted through the mouth into the stomach. Once the device is in place, suction is used to gather together tissue from both sides of the stomach into the device. The collected tissue is then fastened together with titanium staples. The procedure creates a small stomach pouch, shaped like a narrow sleeve, at the top of the stomach. Once the stomach is stapled and the procedure is complete, the device is removed from the body.
Results - How it Promotes Weight Loss
The TOGA® System creates a small stomach pouch at the stomach entry, which catches food as it enters the stomach. This slows the movement of food and gives patients a feeling of fullness after eating only a small meal. The overall effect is to help patients feel full faster and eat smaller portions. It is designed to achieve weight loss similar to other restrictive bariatric surgeries.
Benefits of the TOGA System
The TOGA® System is less invasive than other bariatric procedures, because it is performed through the mouth and does not require any surgical incisions. This allows for a quicker recovery and shorter healing time. Also, since it does not use an implant, such as a gastric band, it does not have the associated implant problems.
The TOGA System:
- is incision-free
- does not use an implant
- does not involve intestinal cutting or rerouting
- is less invasive, requires less recovery time, and should cause less complications than other bariatric procedures
- is designed to achieve weight loss similar to other restrictive surgeries
The TOGA US Clinical Trial
The TOGA® System is currently in the investigational stage in the United States. The purpose of the study is to evaluate the safety and effectiveness of the procedure for the treatment of morbid obesity. The title of the study is: Pivotal Clinical Study - TOGA®: A Randomized, Sham-Controlled Trial to Assess the Safety and Effectiveness of Transoral Gastroplasty in the Treatment of Morbid Obesity.
TOGA Weight Loss Video
The following video is an overview of the TOGA® System.
The purpose of the US pivotal study is to evaluate:
- Effectiveness of the TOGA® Procedure (weight loss)
- Safety of the TOGA® Procedure
- Effect on obesity related illnesses
- Effect on quality of life measures
- Changes in medication use
The FDA clinical trials started in the summer of 2008, but prior to that time the procedure was performed at medical centers in Mexico and Belgium in a pilot study between February 2006 and July 2007. Participants weighed an average of almost 120 pounds over their ideal body weight. At six months post-surgery, patients had lost more than a third of their excess body weight. At 12 months, excess weight loss averaged almost 40 percent.
The TOGA® System is a medical treatment for individuals who are morbidly obese. The clinical definition for morbid obesity is patients whose body mass index (BMI), a weight-to-height ratio, is at least 40, or patients with a BMI between 35 and 40 who also have one or more obesity-related diseases such as type 2 diabetes, sleep apnea, or high blood pressure.
Obesity is affecting the health, quality of living, and length of life for millions of Americans. Although the current bariatric procedures, such as gastric bypass and gastric banding, are considered effective obesity treatments, many individuals are unwilling to undergo a surgical procedure to lose excess weight.
The new TOGA® System looks to be a promising new approach to treating obesity that would appeal to many more individuals than the current bariatric surgeries. For now, we must wait for the results of the study to see if the TOGA® System will indeed prove to be a viable bariatric treatment.
Updated FDA Status of TOGA: Weight loss results during clinical trials was less than the company hoped for; further research and development put on hold at this time; not yet approved by FDA.