Experimental Weight Loss Surgery:
The 4 Most Promising Procedures
Experimental weight loss surgery procedures are those that have yet to receive approval from the professional bariatric surgery community or the FDA.
Despite their investigational status, we've got our eye on six promising procedures, some of which have the potential to change the very meaning of bariatric surgery...
- How do investigational procedures get approved?
- How do experimental bariatric surgery devices get approved?
- The 4 most promising experimental/investigational procedures:
- Can you receive an experimental procedure?
- Free local surgeon consultation: Click here to schedule a free consultation with a local qualified surgeon to learn more about these procedures vs the more established procedures
How Do Investigational Procedures Get Approved?
Before new weight loss surgery procedures can be widely marketed and performed, they must first pass a series of four clinical trial phases:1
To Be or Not to Be... Experimental
"Experimental" means different things to different people.
For example, despite the wide use and approval of gastric sleeve surgery in the professional weight loss surgery community, some insurance companies still don't cover it. They consider it experimental because they are awaiting broader long-term results.
This page applies the consensus of the professional weight loss surgery community regarding the current status of a procedure.
- Phase I: Initial testing in a small group of 20 to 100 people to evaluate the safety and identify side effects of the new treatment.
- Phase II: A larger group of 100 to 300 people receive the treatment to further test its safety and effectiveness.
- Phase III: The treatment is given to an even larger group (up to 3,000 or more people) to "confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental treatment to be used safely." This phase is typically where the FDA gets involved if a new device is being used (more on this below).
- Phase IV ("Post Marketing Surveillance Trial"): Ongoing testing after the treatment has been marketed and is widely in use for the purpose of evaluating long-term results.
If a new device is used during the procedure (rather than just a new technique being performed), the device must receive FDA approval before it can be marketed and used...
How Do Experimental Weight Loss Surgery Devices Get Approved?
Class III devices are those that "support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury."
New medical devices must receive U.S. Food & Drug Administration (FDA) Class III Premarket Approval Application (PMA) approval, the most stringent type of device marketing application, before they are allowed to be marketed and used.2
FDA approval or denial is determined by an "appropriate FDA advisory committee". Technically, the process is supposed to be completed within 180 days, but it often takes much longer.
The FDA does not provide status updates regarding the review of particular devices. They only commit to "reviewing and approving or clearing products in a timely fashion."
The 4 Most Promising Investigational/ Experimental Weight Loss Surgery Procedures
Following are the six most promising experimental weight loss surgery procedures (listed alphabetically):
- EndoBarrier Gastrointestinal Liner
- Implantable Maestro System
- TOGA bariatric surgery
- Transoral Gastric Volume Reduction (TGVR)
EndoBarrier Endoluminal Liner
The EndoBarrier gastrointestinal liner from GI Dynamics attempts to mimic the effects of gastric bypass surgery without the risks of major surgery.
It’s designed to work by inserting a flexible tube-like barrier into the top part of the small intestines. The barrier is placed endoscopically via the mouth and is proposed to help patients lose weight by delaying digestion until farther down the intestines.
The Endobarrier appears to be less impactful than other options in terms of weight loss (about 19% average excess weight loss) and more geared towards improving health conditions like diabetes.6 Most of the diabetic patients in the clinical trials have shown improvement in the disease.
The EndoBarrier is currently considered investigational and is undergoing clinical trials and investigational studies. For demonstration videos, click here.
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Implantable Maestro System
EnteroMedics Inc. has developed a device called the Maestro System that, according to the company, has produced “clinically significant weight loss and control of obesity related co-morbidities as well as a safety profile that distinguishes this system from all other bariatric surgical procedures.”
The system works by manipulating the body’s vagus nerves, which start in the brain and branch out to several organs throughout your body. While the impact the nerves have on obesity is uncertain, they are known to play a role in obesity-related body functions, including expanding the stomach, emptying stomach contents and creating sensations of hunger.
The Maestro System, which is implanted into the vagal nerve trunks found in the front and back of the esophagus, delivers “high frequency, low energy electrical impulses” through what EnteroMedics calls VBLOC Therapy to “block the messages conveyed through the vagal nerves.”
So far, the company has reported:
- Meeting all of its safety goals
- No therapy-related serious adverse events
- Improvements in glycemic control
- Improvements in blood pressure
- Clinically meaningful weight loss
VBLOC therapy is not yet available or approved for use in the United States and continued research is needed to confirm the results. For more information, see EnteroMedic’s website.
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TOGA Bariatric Surgery System
The TOGA bariatric surgery system is a relatively new restrictive procedure that aims to facilitate weight loss by shrinking the stomach size using staples instead of incisions or permanent devices.
The technique has shown promising possibilities and appears to be safe, but further refinement is needed to increase the likelihood that the staple line will remain intact.5
According to Satiety, Inc., maker of the TOGA System, the procedure has 7 steps:
- With the patient under general anesthesia, the TOGA Sleeve Stapler is inserted through the mouth into the stomach
- The stomach tissue is spread and positioned using a retraction device
- Applying suction, tissue from the anterior and posterior of the stomach is collected into the device
- The device is closed, and titanium staples are delivered.
- This creates a sleeve at the entry of the stomach, along the lesser curve.
- The TOGA Restrictor is inserted, and is used to narrow the bottom of the sleeve.
- The resulting pouch is designed to collect food as it enters the stomach, giving patients a feeling of fullness after a small meal.
The following video from Satiety, Inc. explains further:
The system has not yet been approved by the FDA and is considered an investigational device.
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Transoral Gastric Volume Reduction (TGVR)
Transoral Gastric Volume Reduction is a relatively new
restrictive procedure that has shown
encouraging
results.
It works by sewing the sides of the stomach to create a feeling of
fullness (it’s primarily restrictive) by not allowing the stomach to
relax.
According to Brigham and Women’s Hospital1, the organization who conducted the first-ever study on this new procedure…
“Under general anesthesia, the scope is inserted through the mouth and into the stomach. A series of two-or three-bite stitches are placed to appose the anterior and posterior gastric walls in the body and fundus, thereby reducing the expansible volume of the proximal stomach. Patients are typically able to return home approximately two hours following the procedure.”
More time and research are needed before we’ll feel comfortable recommending this procedure, but for now it looks promising.
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Can I receive an Experimental Weight Loss Surgery Procedure?
As long as your surgeon is performing the procedure because he or she deems it to be in your best interest, the government will not step in to prevent an experimental weight loss surgery from being performed.3
To learn all about clinical trials, including their benefits and risks, see ClinicalTrials.gov's Understanding Clinical Trials page.
To review the current list of clinical trials for bariatric surgery, click here.
If you aren't working with a surgeon that is experienced with the surgery that you're interested in, you may be able to find one if you are willing to participate in a clinical trial. In order to qualify, you'll need to meet the specific criteria set by the researchers.
Either way... after determining that you are working with an experienced and qualified weight loss surgeon, confirm that his or her hospital has a review board that oversees experimental procedures.
Before moving forward with any investigational procedure, it is extremely important that you understand all of the risks and "unknowns" about the procedure or device:
- Interview at least two or three surgeons (over the phone if there are not enough qualified surgeons in your area and you aren't able to travel to meet them) and ask to speak directly with their patients who have received the procedure.
- Talk directly with a local qualified weight loss surgeon (even if they don't perform experimental procedures) to get their take on the pros and cons. The consultations are usually free, an they will allow you to learn about your options directly from a surgeon.
For additional research, search for your topic...
Also see...
References
- Understanding Clinical Trials. ClinicalTrials.gov. Available at: http://clinicaltrials.gov/ct2/info/understand
- Medical Devices - PMA Approvals. FDA U.S. Food and Drug Administration. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/
PMAApprovals/default.htm - Kolata, G. Ideas & Trends; Do Surgeons Need More Government Regulation? New York Times. May 1988. Available at: http://www.nytimes.com/1988/05/01/weekinreview/
ideas-trends-do-surgeons-need-more-government-regulation.html - Fobi Mal, Lee H, Felahy B, et al. Choosing an operation for weight control and the transected banded gastric bypass. Obes Surg. 2005;15:114–121.
- Moreno C, et al. Transoral gastroplasty is safe, feasible, and induces significant weight loss in morbidly obese patients: results of the second human pilot study. Endoscopy. 2008 May;40(5):406-13.
- Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010 Feb;251(2):236-43.
[Last editorial review/modification of this page: 11/8/2011]
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