Interview with Dr. Randal Baker, Creator of Full Sense DeviceApril 16, 2015
ObesityHelp.com has been contacted by members of the OH community and individuals that are struggling with obesity about the Full Sense Device. ObesityHelp reached out to Randal Baker, M.D., F.A.C.S., creator of the Full Sense Device, for an interview about the Full Sense Device. For information on what the Full Sense Device is and how it works, read the Full Sense Device to Combat Obesity article. We appreciate Dr. Baker discussing the in-depth information on the Full Sense Device and weight loss surgery from a patient's perspective in this interview.
Who is the ideal patient for Full Sense?
Dr. Baker: The ideal patient would be someone who is obese or morbidly obese, desires weight loss and is healthy enough to undergo conscious sedation and endoscopy, and has been evaluated by a comprehensive multidisciplinary team. The BMI minimum will depend on the regulatory approval process in each country that the device is approved in. Currently, our plans for an initial "Indications For Use" will be limited to patients with a BMI of 30 or higher. For a patient with a high BMI, the only limitations would be the safety of placing the device. The patient would have to be able to safely undergo endoscopy. Some patients with a high BMI might need general anesthesia to maintain a safe airway during endoscopy.
The medical contraindications for placement of the device would be severe reflux with a large hiatal hernia which would need to be repaired first. Any type of cancer would also be prohibitive. The full list of contraindications have not yet been finalized and will be available after our studies are completed.
What are the age requirements for placement of the Full Sense device?
Dr. Baker: The age limitations have not yet been set. It would potentially be ideal for older children and adolescents because of its non-invasive yet effective nature. Further studies will be needed to completely answer this question. If a child is morbidly obese, the Full Sense potentially could be an option. Different sizes are needed to fit the anatomy of children. If a child is morbidly obese, the Full Sense could potentially be an option. An adjustable version may be more appropriate and would give the clinician the ability to titrate the response to the individual child to avoid interference with growing and other vital nutrition-dependent functions. As to the upper age limits, it will need to be determined on an individual basis reflecting each patient's current health status.
What are the advantages between Full Sense versus weight loss surgery?
Dr. Baker: There are several advantages of the device. The main one is that it is much less invasive and does not require surgery or incisions. Nothing in the body is rerouted or removed during the procedure. It can be performed on an outpatient basis, allowing patients to return to work and activities much faster. The weight loss is more consistent and can reach a higher percentage of overall weight loss because the device is direct and not food-dependent.
We have seen improvement in co-morbid conditions similar to what occurs with bariatric surgical procedures. The Full Sense puts pressure on the top of the stomach to trigger signals and hormones that cause weight loss. In light of its safety profile and non-invasive nature, the device can eventually be placed for patients earlier in the obesity process who do not yet meet criteria for consideration of surgery. It will also likely be safer for patients who are too high of a risk for invasive procedures.
How will surgeons be trained on the placement of the Device?
Dr. Baker: We have already identified centers in Europe and Canada to be trained. We will be training surgeons in those centers soon in anticipation of CE approval. These centers are skilled bariatric centers with surgeons who have extensive research expertise as well. We anticipate that those centers would then serve as training sites for others.
What is the process to have the Full Sense placed and dietary guidelines?
Dr. Baker: The patient undergoes conscious sedation, and the device is placed and secured using an endoscope as well as the endoscopic delivery device. The present version is held in place using temporary clips while it achieves long-term stability with mucosal in-growth. (Note - Some higher risk patients may require general anesthesia if there is a concern for airway protection during conscious sedation.) Recuperation is very quick, most people can return to normal activities once the sedation medications are out of their system. After the placement, the patient goes on a liquid diet for two weeks while the in-growth stabilizes. Patients can then progress to a general diet as long as food intake is chewed well. The dietary recommendation for the Full Sense is a healthy high protein diet.
Is the Full Sense similar to the Stomaphyx?
Dr. Baker: No, the Stomaphyx is used to tighten an existing pouch or to try to create a new pouch of some sort in the stomach. It is a food based scenario requiring food to come into the pouch to create the effect. The Full Sense acts directly by applying pressure and stretches to the top of the stomach to send signals to the brain and rest of the body. The Full Sense is completely removable. The Stomaphyx changes are not.
Are there any risks to the Full Sense?
Dr. Baker: The risks are very similar to endoscopic procedures such as esophageal stents and intragastric balloons. In addition, patients will experience some immediate discomfort from pressure which usually diminishes over time. During the development of the device, the biggest hurdle to overcome was migration. Migration was heralded by return of hunger when it occurred. In smaller patients, a larger device can lead to heartburn and reflux which can usually be controlled with acid medications if necessary. Some patients noticed shoulder discomfort if they would eat too fast or not chew well. The first generation of the device is temporary so there is always a chance of recidivism. (We hope to have small devices available for these patients in the future.)
Have any patients had adverse reactions or rejection of the device?
Dr. Baker: No, that would be very atypical. The stent is made of nitinol wire covered by silicone which has been used in numerous medical devices for many years. The good news is that the device is easily removed if any type of reaction occurs. The biggest obstacle to overcome in development was the migration issue mentioned previously but no rejection or adverse reactions have occurred seen so far.
What will a patient experience if they overeat with the Full Sense?
Dr. Baker: The patient would become very full and may progress to nausea. Most patients have enough pressure to deliver slight fullness that removes hunger. As a result, we have not seen much overeating at all in our patients so far. The increased satiety seems to actually lead to less overeating. Any food taken in causes additional temporary fullness so overeating is less likely to occur.
Will the Full Sense help a patient with head hunger or emotional eating?
Dr. Baker: Thus far, we have no patients who have not continued to lose weight with the device in place. That being said, good consistent counseling would be recommended for these types of patients for when the device is removed. More studies will be needed to completely answer this question.
When the Full Sense is removed, how will a patient feel satiety and prevent regain ?
Dr. Baker: Many obese and morbidly obese patients have enlarged stretched stomachs at baseline. Since the Full Sense causes less food intake without restriction, the stomach size actually decreases over time. Patients notice less fullness with the device out, but more than before the device was placed. As to regain, with the temporary first generation device, a patient will need to readjust their behaviors during implantation. We advise working with a multidisciplinary team on dietary and exercise protocols. Fortunately, loss of significant weight allows the patient to feel much better and it is a lot easier to be active.
Can people that have already had weight loss surgery have the Full Sense Device?
Dr. Baker: The Full Sense would deliver additional satiety to weight loss surgery patients. The device could even be placed prior to surgery in super morbidly obese patients that need to lose weight before surgery or for those who are having difficulty getting down to their goal weight. At this time, the first generation of the Full Sense device is designed for patients without bariatric surgery. The company has designs and plans for a second generation for patients that have had weight loss surgery but the timing is unclear at the present.
For weight regain, would the Full Sense be better than getting a revision?
Dr. Baker: The main issue would be the reason for the revision. This would need to be evaluated in consultation with an experienced bariatric surgeon and multidisciplinary team. If the revision is for weight loss alone, then this may be a good option. This is because the Full Sense is not a food based system as it provides continuous satiety.
Can the device be placed a second time if a patient has regain?
Dr. Baker: Yes, the device can be placed again. Eventually an adjustable Full Sense device would be ideal for someone who has recidivism despite maximal efforts. This is planned after the release of the first generation device.
How much will the cost be and what are the results so far?
Dr. Baker: The cost of the device and implant procedure is unknown at the present time. It is expected to be considerably less than the cost of traditional weight loss procedures.
We have placed the device in over 109 patients to date. The first study was for six weeks but we have increased the time interval since then. The longest period of time it has been in a patient was under one year. We have removed devices when 100% of EBWL was achieved or if the study protocol called for earlier removal. The length of placement for weight loss depends on the beginning weight of the patient. A heavier patient will take longer to lose their weight while patients with a lower BMI will likely only need it for several months.
When will the Device be available to patients?
Dr. Baker: It should be available in the European Union countries in late 2015. Data will be collected and then the device will be brought to the FDA. Once the device is available in Europe, we expect other countries such as Mexico and Canada to likely follow closely behind. The approval will be greatly facilitated in those countries by the CD approval in Europe.
Are you accepting new study patients at this time?
Dr. Baker: At this time, we are not taking study patients. We have received hundreds of requests for this including long 2-3 page letters that beg to be included in the studies. We understand the plight of many impacted by obesity and truly want to help in the battle of obesity by getting the device approved. The best way to follow the progress of its approval is to check on the BFKW website.
What else would you like us to know?
Dr. Baker: Your questions were quite comprehensive! We appreciate the questions and keep up the great work in helping many people to better understand the epidemic of obesity. This is not the time to shirk from the battle! I also want to tell those who are suffering in the throes of obesity and weight issues that there is hope. A significant amount of good research is happening today in many scientific circles and I am convinced we will begin to reverse this obesity trend.
ObesityHelp would like to thank Dr. Randal Baker for the opportunity to talk with him about the Full Sense Device and the important information he shared with the OH community and those struggling with obesity.
Photo credit: Dr. Randal Baker
ABOUT THE AUTHORRandal Baker, M.D., F.A.C.S. is a native of Grand Rapids, Michigan. He graduated from South Christian High School and then received his B.A. from Calvin College. He earned his M.D. from Albany Medical College of New York. He is an Assistant Professor of Surgery for Michigan State College of Human Medicine and currently serves as the Medical Director of Bariatrics for McLaren Northern Michigan Regional Hospital.
Read more articles from Dr. Randal Baker!