One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported.

Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to < 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.

Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH< 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.

64 patients from Livingston Hospital and Healthcare Services in Salem, Kentucky, and 60 from Munroe Regional Medical Center in Ocala, Florida were eligible to participate in the study but 110 signed consent and started. 13 eligible patients were lost to follow up at start of study, and one did not have Transoral Incisionless Fundoplication (TIF) completed due to intraoperative hematoma.

median number of years of GERD symptom duration is 9 years

median number of years of PPI duration therapy is 8 years

This is a subjective measure made by the study investigator using endoscopic visualization of the gastroesophageal junction. Normal or small hiatal hernia is <= 1cm. Hill Grade system is used: Hill I, II, III, IV, with Hill I normal hiatus and Hill IV large, loose hiatal opening. Hill IV is an exclusion for this study.

Hill II may indicate a 2cm hiatal hernia, Hill III a 3cm hiatal hernia for example.

70 of 110 participants had a 2 or 3cm hiatal hernia at baseline

LA grading of esophagitis is an A, B, C, D system, where A is the least severe esophagitis and D is the most severe. LA grade D is an exclusion for this protocol. Normal or no esophagitis reported, will have no grade listed. LA grading is a subjective measure made using an endoscope to visualize the gastroesophageal junction to assess for esophagitis based on the LA grade criteria. An improvement of one grade post-TIF is considered a success, e.g., from grade B to grade A, or grade A to no grade (normal), etc.

64 of 110 participants had esophagitis at baseline

The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.

There were no serious adverse events or UADE during the study.

Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.

One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported.

Of 53 patients examined at follow up for esophagitis or hiatal hernia status, 30 had reported esophagitis at baseline. Please note: there was 1 new case of esophagitis reported at follow-up, that had not been present at baseline.

Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to < 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.

53 patients were assessed for esophagitis and presence of hiatal hernia at follow-up. Hiatal hernia was present at baseline and reduced during TIF procedure in 34 of the patients examined at follow-up. Hiatal hernia in 33 of 34 remained reduced at follow-up. Please note: there was one new case of hiatal hernia reported that had not been present at baseline.

Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH< 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.

Note: neither 48-hour Bravo pH nor 24-hour impedance/pH testing was completed. pH testing was unavailable at the study sites. Study protocol noted that testing would be completed "if available". In the absence of these testing tools, sites relied on detailed history, physical signs, symptom evaluation, barium swallow, and repeated esophagogastroduodenoscopy (EGD) with biopsy to make diagnosis. This continues to be the most commonly used method of GERD diagnosis among community physicians.