EndoGastric Solutions (Redmond, Wash.) said that a clinical trial of a transoral incisionless fundoplication (TIF) 2.0 procedure using its EsophyX device improved PH rates and clinical outcomes in patients with gastroesophageal reflux disease (GERD).

The patients underwent laparoscopic hiatal hernia repair followed by the endoscopic TIF 2.0 procedure using the company’s EsophyX device. EsophyX is used to reconstruct the gastroesophageal valve and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus.The new study is a retrospective analysis of 97 GERD patients evaluated between October 2015 and December 2017 with mean follow-up evaluation at 296 days. Fifty-five of those patients underwent hiatal hernia repair and the TIF procedure. Of these 55 patients, 29 (53%) had matched pre- and post-operative assessments. Among the 29 patients:

• 21 of 22 who had intact repairs at follow-up showed normalization of pH scores (95%).
• Average PH scores improved from the baseline of 35.3 to 10.9 at follow-up (p<0.01).
• Average GERD health-related quality-of-life scores improved from baseline 33.75 to 9.07 at follow-up (p<0.01).
• Average Reflux Symptom Index (RSI) scores improved from a baseline of 20.32 to 8.07 at follow-up (p<0.01).

The retrospective data are reported in a paper titled “pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication,” and appear in the January – March 2019 issue of the Journal of the Society of Laparoendoscopic Surgeons.

“This is the first study to demonstrate that a concomitant hiatal hernia repair and TIF 2.0 procedure yields statistically significant improvements in pH exposure, an objective measurement in the treatment of GERD,” said lead author and general surgeon Glenn Ihde, M.D., of the Matagorda Medical Group in Bay City, Texas, in a prepared statement. “Significantly, pH scores were normalized in 95 percent of patients with intact hiatal repair at follow-up assessment. This patient group also experienced a decrease in bloating syndrome related to traditional laparoscopic fundoplication. These promising results warrant further evaluation in additional prospective studies of this set of concomitant procedures.”

“These findings support the safety and efficacy of concomitant hernia repair and TIF 2.0 procedure with the EsophyX device,” added EndoGastric Solutions president and CEO Skip Baldino. “This is an important advance for patients with hiatal defects of two centimeters or more, as the data show improved objective and subjective assessments of GERD symptoms. We look forward to additional prospective studies to provide physicians with additional data surrounding improved outcomes for their patients utilizing this approach.”