Inclusion/Exclusion criteria: Inclusion:
Patients with chronic GERD symptoms (at least 1 typical symptom of GERD, i.e.
heartburn or acid reflux/regurgitation at least twice a week) for last 6 months and
Objective evidence of reflux disease (positive ambulatory pH study)
Patients prescribed standard dose of PPI for symptoms of GERD
Able to undergo upper endoscopy as evidenced by completion of pre-endoscopy standard
of care checklist.
Exclusion:
Patients unable to or unwilling to participate or consent
Age <18 years or >80 years
Allergic or intolerant to PPI medications
Large hiatal hernia > 3 cm and Hill grade IV
Barrett's esophagus
Esophageal stricture with any prior intervention
Major motility disorder on HRM
Eosinophilic esophagitis 8. Gastroparesis documented by abnormal gastric emptying
time 9. Previous fundoplication, myotomy or LINX surgery 10. Cirrhosis with
esophageal and/or gastric varices
Study groups:
Patients recruited will be randomized to undergo antireflux mucosal ablation (ARAT) OR
sham intervention after inclusion and exclusion criteria have been met.
Study procedure:
Patients will be randomized (1:1) to one of the arms by computer generated random
sequence of numbers.
The following study visits are foreseen for each patient:
Screening Visit(s) A screening visit is performed at the investigational site. During
this visit out-patients will be informed about the aims, procedures, benefits and
possible risks of the study prior to signing the informed consent form for inclusion in
the study. Their medical history will be recorded as well as eventual clinical or
laboratory examinations according to the local standard of care preparation for an upper
endoscopy.
Randomization (Intervention) visit: Each eligible patient returns to the clinic to
undergo either the study intervention OR sham intervention.
24-48 hour and 7-10 day post randomization phone call for adverse events among both
groups.
25-30 day post randomization phone call for adverse events among both groups.
3-4 Month (80-112 days post randomization) visit with upper endoscopy and ambulatory pH
monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
6-7 month (165-196 days post randomization) visit phone call to include administration of
the validated GERD-HRQL and RDQ questionnaires
11-12 month (336-365 days post randomization) visit with upper endoscopy and ambulatory
pH monitoring to include administration of the validated GERD-HRQL and RDQ questionnaires
To determine if ARAT can improve GERD-HRQL score 50% compared to sham intervention
at 3, 6 and 12 months
To determine if ARAT can decrease GERD scores (RDQ) 50% compared to sham
intervention at 3, 6 and 12 months
Secondary aims:
To determine if ARAT can reduce esophageal acid exposure time <4% (using wireless
ambulatory 24-hr pH monitoring) in 50% subjects compared to sham intervention at 3
and 12 months
To determine if ARAT can achieve 50% reduction in DeMeester score compared to sham
intervention at 3 and 12 months
To determine if ARAT can achieve PPI dose reduction or discontinuation in 25% of
subjects after 3 months compared to sham intervention
To evaluate the safety profile of ARAT the rapy by recording major (GI bleeding,
perforation, hospitalization, esophageal stricture) and minor complications (chest
pain, fever, dysphagia) 7.5. Follow up Following the baseline assessment and
performance of the upper endoscopy (either true intervention or sham), patients in
both groups will be asked to complete the GERD-HRQL and RDQ questionnaires at 3
month ,6 month and 12 months using appropriate case report forms. In addition, the
study staff will contact the patients by phone call at day 24- 48 hours, by phone
call at 7-10 days and 25-30 days post procedure to record any adverse events. This
will be accomplished using designated case report forms. At months 3 and 12, all
patients will also undergo an upper endoscopy with assessment for
erosive esophagitis, and placement of pH capsule. During the 3 month, 6 month and 12
months visit, use of PPI therapy (dose and frequency) will be recorded. Response to
therapy will be assessed using the following parameters: improvement of GERD-HRQL scores,
reduction in RDQ scores, AET <4% and DeMeester score <14 (off PPI). Any patients with
dysphagia after the ARAT will undergo repeat endoscopy for evaluation. If significant
stricture, endoscopic dilation will be performed per severity of symptoms and stenosis.
Duration of this study from subject randomization to completion is 1 year, however, we
anticipate study duration of at least 24 months for subject screening, completion of
study visits and data analysis.