Digestive Health Patient Undergoes Groundbreaking Anti-Reflux Procedure

As a veteran of both the United States Coast Guard and the Army National Guard, Tyler Cronin knows what it means to be part of something bigger than himself. On August 18, 2023, the 37-year-old made history as the first patient in the world to receive a novel implant to treat gastroesophageal reflux disease (GERD), commonly known as acid reflux.

Tyler’s treatment marks the beginning of the first clinical trial for the Omega PF™, a small, flexible cuff that wraps most of the way around the lower esophagus. The procedure was performed by UT Health Austin board-certified surgeon F. P. “Tripp” Buckley III, MD, FACS, who serves as the Surgical Director of Digestive Health, a clinical partnership between Ascension Seton and UT Health Austin.

Learn more about what the Omega device could offer reflux patients.

<br>The significance of this milestone is not lost on Tyler. “I knew that if my experience could pave the way for a new treatment option for patients with GERD, then my participation in the research study would be worth it,” shares Tyler.

The Search for Reflux Relief

Tyler first experienced symptoms of GERD in 2018. “I didn’t know what my symptoms meant back then, but I could tell that something was wrong when I was regularly throwing up so much stomach acid that it ate away at the porcelain finish on my toilet,” he recalls.

Explore the relationship between heartburn, acid reflux, and indigestion.

<br>When a severe episode of his symptoms landed him in the emergency room, Tyler made an appointment with a gastroenterologist to discover the root cause of his pain. There, he underwent an endoscopy and was diagnosed with GERD but was told little could be done for his condition outside of diet and exercise.

“Back and knee pain related to my military service made exercise difficult, and up until this year, I just lived with my pain,” explains Tyler. “I tried to manage my condition with proton-pump inhibitors and over the counter medications. I avoided spicy foods and eating after 5:30 p.m., because I knew that as soon as I laid down, I would have that really intense burn that would wake me up at night. There were nights when I would only get two or three hours of sleep, making it hard to function the next day.”

Tyler sought a referral to Dr. Buckley after this five-year struggle to keep his symptoms at bay. Although he resides in College Station as a student at Texas A&M University, he learned about Dr. Buckley from a friend who was successfully treated for GERD by the Heartburn and Esophageal Disorders care team within Digestive Health.

“My friend’s symptoms went away after he was treated by Dr. Buckley,” says Tyler. “Based on this positive experience, I knew I would be in good hands.”

A New Option for GERD Patients

Dr. Buckley confirmed Tyler’s condition with another endoscopy and informed him of the many surgical treatment options for GERD, including the Omega GERD research study, an early phase Food and Drug Administration (FDA) investigation funded by the National Institutes of Health (NIH). The research study aims to evaluate the Omega device as a potential treatment for reflux symptoms.

The current gold standard in anti-reflux surgery in the United States is a procedure known as Nissen fundoplication in which the lower esophageal sphincter is reinforced by wrapping tissue from the upper part of the stomach around the lower esophagus to prevent stomach acid from traveling into the esophagus.

“Nissen fundoplication is associated with excellent surgical outcomes when performed by an experienced surgeon, but the Omega device promises a quicker and easier procedure for surgeons, decreasing the likelihood of complications and side-effects,” explains Dr. Buckley. Rather than using stomach tissue, the Omega device reinforces the lower esophageal sphincter with a thin, metallic cuff wrapping three-quarters of the way around the esophagus.

Tyler experienced firsthand the speed and simplicity of the Omega device implantation. “The procedure itself took less than two hours,” shares Tyler. “Once the placement of the device was confirmed with X-ray imaging, I was driven back to College Station that same day.”

Two weeks later, Tyler returned to Austin for a follow-up visit with Dr. Buckley. While he had experienced a buildup of scar tissue around the esophagus, a common temporary side effect of the procedure that temporarily made it difficult for him to eat, he reported that all his GERD symptoms had subsided after his treatment.

“I’m thankful for Dr. Buckley and his team and look forward to living pain-free, getting more sleep, and being able to function better,” shares Tyler.

Towards Better Reflux Surgery for All

The Omega device research study will assess the feasibility of the implantation process over a five-year period before the device can be evaluated with the multicenter clinical trial needed for Food and Drug Administration (FDA) approval.

“Digestive Health was approached to study the device at such an early stage in the research process because of our high volume of anti-reflux procedures performed at our clinic, with over 400 procedures performed each year, and the clinic’s relationship with the Dell Medical School at The University of Texas at Austin,” explains Dr. Buckley.

The Heartburn and Esophageal Disorders care team is involved in various research projects, including an ongoing multicenter clinical trial comparing laparoscopic Nissen fundoplication (LNF) to a procedure known as transoral incisionless fundoplication (TIF) for GERD patients who also have a hiatal hernia. This clinical trial is expected to continue through the end of 2023 and is currently enrolling patients.

“Alongside our excellent surgeons, as an academic medical center we have the research infrastructure and personnel to support us in these clinical trials,” explains Dr. Buckley.

Tyler echoes this sentiment, putting aside longtime college rivalries in the name of medicine. “I’m grateful that the Dell Medical School has the doctors and research programs to work towards better treatments for UT Health Austin patients like me.”

For more information or to schedule an appointment with Digestive Health, call 1-844-GI-AUSTIN (1-844-442-8784) or visit here.