Device in clinical trial stops woman’s acid reflux

Debra T.’s acid reflux disease was once so bad she couldn’t sleep unless she was sitting up. She also couldn’t eat any spicy food, could only eat small portions and had to drink milk with her meals.

At one point, even water burned Debra’s esophagus, the tube connecting the mouth and stomach. The constant irritation left her with a raspy voice. Plus, she was tormented every night by a feeling that she was choking.

“I would wake up and fly out of bed, because I was struggling,” explains Debra, a 67-year-old retired care facility office manager from Surprise. “The coughing spell would finally go away, and I would go back to bed. But that happened every night.”

GERD diagnosis and initial treatment

Gastroesophageal reflux disease (GERD) is a condition in which stomach acid repeatedly flows back up into the esophagus. This backwash is known as acid reflux, and severe cases can irritate the lining of the esophagus.

“I used to wake up in the middle of the night choking, and I didn’t know why,” says Debra. “I would just wake up coughing, coughing, coughing. I didn’t know what it was. I couldn’t figure it out, ‘Why am I choking?’ I now think that was the onset of my GERD.”

Debra was diagnosed with GERD in 2012 but was without sufficient health insurance that would grant her anything but over-the-counter medications. After securing better insurance, she started taking more effective prescription medications. “It helped a lot,” she adds.

But her overall frustrations with her medical condition persisted, even after signing up for a clinical trial. She initially was rejected because a prior hernia she suffered might hamper the operation.

“I was so heartbroken,” Debra recalls. “I was like, ‘Man, I cannot live like this the rest of my life.’ I kept telling them, I want to lay flat (to sleep) before I lay flat in my coffin. I just gave up.”

Device in clinical trial stops woman’s acid reflux - Debra's story

A new clinical trial offers hope

Eventually, she was contacted by HonorHealth Research Institute’s GI/Bariatric Research Division about a new, less-invasive clinical trial involving a device called the Omega-Cuff. Shaped like the Greek letter Ω, the cuff is designed to prevent excessive acid from entering the esophagus while allowing much of the normal swallowing process to remain intact.

The device, part of a first-in-human study, is placed on top of the esophageal sphincter muscle, just above the stomach. In laboratory studies, the device increased resistance to acid reflux, but did not interfere with normal food swallowing. This is a permanent implant, and that is just fine with Debra.

“Since that surgery, I have not had to take any acid-reflux medicine,” shares Debra, who feels “wonderful” and is grateful for the simple act of bending over, “without puking.”

She visits the Research Institute for monthly follow-ups, describing her care as “very awesome.” She describes the device as “the best thing ever!”

“I am so excited – there’s no negative impact,” Debra explains. “And I can eat spicy food! It’s wonderful.”

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