Tuesday, July 20, 2010

Weight-loss surgery through the belly button or through the mouth

The TOGA System

TOGA Weight Loss 
The TOGA® System is less invasive than other bariatric procedures and does not require any surgical incisions.
The TOGA® System is a promising 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.

About TOGA

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

TOGA Weight Loss 
Surgery The TOGA® System creates a small stomach pouch, shaped like a sleeve, to catch food as it enters the stomach.
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.
Play time: 2 min 44 sec  Go to website to see video

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.

Patient Criteria

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.
Although clinical trials have started, volunteers are still being accepted to participate in the investigational study. Volunteers must be 18 to 60 years old and at least 100 pounds over their ideal to meet initial patient criteria. Individuals who are interested or want more information about the TOGA® study may call 1-866-678-8399 or visit online at www.togaclinicalstudy.com.
Update: The study in ongoing, but not recruiting participants at this time.


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.

The Spider System 

A medical-device company and a bariatric surgeon team for weight-loss surgery requiring just one incision. By Colin Stewart resource: http://seattletimes.nwsource.com/html/health/2012395005_navel20.html

A medical-device company in North Carolina and bariatric surgeon Dr. Brian B. Quebbemann of Newport Beach, Calif., have teamed up for weight-loss surgery requiring just one incision.

The operation was the first time a surgeon has used a new Spider surgical tool for an increasingly frequent form of bariatric surgery that cuts the stomach down to 20 percent of its normal capacity, Quebbemann said.

The Spider system allows surgeons to operate through the belly button, using a tool containing working arms that unfold inside the patient.

The operation is called "vertical sleeve gastrectomy," which Quebbemann said is one of the fastest-growing types of bariatric surgery. The procedure is most frequently used to treat severely obese patients, but it is also effective for less obese patients with body-mass index of 30 to 35, he said.

It's an alternative to better-known forms of weight-loss surgery — the gastric bypass, in which food is detoured around the stomach, and the Lap-Band, which creates a small pouch at the top of the stomach.

The name "vertical sleeve" describes the shape of the portion of the stomach that remains after the surgery.

Quebbemann, surgical director at The N.E.W. Program weight-loss center in Newport Beach, said the procedure appeals to patients who worry about how a gastric bypass will affect nutrition. It's also an alternative to Lap-Band surgery for patients who do not want "an artificial device attached to their stomach," he said.

The Spider system, produced by TransEnterix Inc. of Durham, N.C., was approved by the Food and Drug Administration last year.

Quebbemann said the Spider device made the operation easier:

"Instead of making several incisions to place my surgical instruments, I simply make one small incision, hidden in the patient's belly button, and insert the Spider. I then expand the internal portion of the device, similar to expanding an umbrella. This allows me to clearly see the anatomy and accurately perform the operation.

"(At the end of the procedure,) I simply close the system, and remove it through the small incision, leaving almost no visible scar."

The company said the device has previously been used for Lap-Band placement, colon surgery and for kidney and gallbladder removals.

The vertical-sleeve operation was performed at the Advanced Surgical Partners Surgery Center in Costa Mesa.

A vertical-sleeve procedure is not a "quick fix" for obesity, warns the Medline Plus online information service, sponsored by the National Institutes for Health.

"It will greatly change your lifestyle. You must diet and exercise after this surgery. You may have complications from the surgery and poor weight loss if you don't," Medline says.

This procedure cannot be reversed. Medline says risks include:

Injury to stomach, intestines, or other organs during surgery.

Leaking from the line where parts of the stomach have been stapled together.

Scarring in the abdomen, which could lead to an obstruction in the bowels.

Inflamed stomach lining, heartburn, or stomach ulcers.

Poor nutrition, "although much less than with gastric bypass surgery."

Vomiting from eating more than the stomach pouch can hold.

"The final weight loss may not as large as with gastric bypass. However, this may be enough for many patients. Because vertical sleeve gastrectomy is a newer procedure, there is less data about the long-term benefits and risks," Medline says.