Treating acid reflux disease today
Acid reflux results from a weak or damaged lower esophageal sphincter (LES) that permits the contents of the stomach to reach the esophagus. When weight management, diet, and lifestyle changes fail to reduce the symptoms of acid reflux, the treatment options are very limited. Alternatives today include either medications to reduce the acidity of the stomach contents, or antireflux surgery. To date there has as been no means to restore the existing LES muscle and improve its barrier capability. That may change soon.
EndoStim: Advancing technology to treat GERD
In 2009 EndoStim, Inc. was formed to treat GERD by strengthening the LES via electrical stimulation. In July 2012 EndoStim received European approval (CE Mark) to market the EndoStim device and since that time, the company has released data on its safety and efficacy.
In early 2016 the company announced a US clinical trial designed to gain FDA approval. Dr. Reginald Bell, MD, a RefluxMD GERD expert serving Denver and the surrounding communities, announced the participation of SurgOne Foregut Institute in this clinical effort. RefluxMD caught up with Dr. Bell to learn more about the device and this interesting clinical trial.
Interview with Dr. Reginald Bell, MD FACS
RefluxMD: Dr. Bell, congratulations on being selected as one of the first GERD experts to participate in the EndoStim clinical trial. Can you tell us more about the EndoStim treatment process?
Dr. Bell: Endostim involves applying neurostimulating electronic current to the nerves around the lower esophageal sphincter, increasing the effectiveness of the lower esophageal sphincter in preventing gastroesophageal reflux.
RefluxMD: EndoStim sounds revolutionary, is there anything like it available today?
Dr. Bell: EndoStim is a completely new and unique technology in the treatment of GERD.
RefluxMD: Can you share with us some of the clinical results from past clinical trials and evaluations?
Dr. Bell: Clinical trials have demonstrated that EndoStim increases lower esophageal sphincter function and decreases the amount of gastroesophageal reflux that occurs, so that 90% of patients were able to discontinue daily use of acid-suppressive medication. These results are similar to other proven techniques to treat acid reflux disease. EndoStim however does not seem to result in swallowing or bloating problems that do infrequently occur with laparoscopic fundoplication.
RefluxMD: When will the clinical trial start and how long will you be working with the company on this effort?
Dr. Bell: The trial is currently enrolling patients and hopes to enroll patients over the next year or two. After enrollment is completed, patients are followed regularly for 5 years.
RefluxMD: For those interested in participating in this clinical examination, can you tell us where they can get additional information?
RefluxMD: As a GERD expert, this treatment may not be for everyone. Can you quickly summarize all the treatment options you deliver to your patients?
Dr. Bell: Interventional Treatment options for GERD that we perform and consider on an individual basis for patients include:
- Laparoscopic fundoplication (total and partial)
- LINX Magnetic Sphincter Augmentation
- Endoscopic fundoplication
RefluxMD: Thank you Dr. Bell and we wish you the best with your clinical trial of EndoStim.
Overview of EndoStim and the treatment of GERD
Gastroesophageal reflux disease (GERD) affects more than 50 million people in the United States. Symptoms such as heartburn, regurgitation, and chest pain can persist despite reflux medications. This is because medications do not address the root of the problem – a valve that is not working properly. The lower esophageal sphincter is the valve between the stomach and esophagus. It allows you to swallow food and liquids, then closes after food/liquids go through to stop fluid from coming back up. There are surgical interventions available today that help the valve close to prevent excess reflux from happening. These procedures are also associated with side effects such as gas, bloating, difficulty swallowing in a small number of patients. New technologies are focusing on reducing GERD without having side effects. One such technology is the EndoStim system. EndoStim is conducting a clinical trial in the United States to evaluate the efficacy and safety of the device for treating GERD. The EndoStim system is considered investigational in the United States and is only available to patients participating in the clinical trial in the United States.
The EndoStim system is a new minimally invasive approach to GERD treatment, designed to restore normal function to the lower esophageal sphincter (LES). The system consists of an implantable neurostimulator and a lead that delivers low energy stimulation to the LES. EndoStim therapy is based on the same electrical stimulation technology that has transformed pain management in recent decades.
The procedure is designed to be uniquely gentle – to preserve natural anatomy in order to reduce or avoid typical gastro-intestinal side effects of traditional anti-reflux surgery.
To learn more about the EndoStim clinical trial and to see if you might qualify to participate, visit www.lessgerd.com.
Dr. Reginald Bell is a RefluxMD GERD expert serving the greater Denver area from his SurgOne offices located in Englewood, CO. Dr. Bell treats achalasia, Barrett’s esophagus, gastroparesis, gastroesophageal reflux disease (GERD), hiatal and para-esophageal hernias, and laryngopharyngeal reflux (LPR). Dr. Bell is also certified to perform the LINX procedure as well as other antireflux procedures including TIF, Nissen fundoplication, RF ablation, stretta, Halo, and Barrx.