This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.
The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, Hong Kong
RECRUITINGImprovement in Gastro Esophageal Reflux symptoms
GERD symptoms evidence by the improvement in the Gastroesophageal Reflux Quality of Life (QoL) of ≥50% compared to the baseline off Proton Pump Inhibitors (PPI) value 3 months after the procedure
Time frame: 3 months
Technical Success
Success in resection of mucosa at cardia by ARMS
Time frame: 1 day
24 hour pH study post ARMS
24 hour pH study
Time frame: 3 and 12 months
High resolution Manometry
HRM
Time frame: 3 and 12 months
Gastroesophageal junction classified by Hill's classification
endoscopic assessment of Gastroesophageal junction
Time frame: 3 and 12 months
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