Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

Phase II Clinical Study on the Safety and Efficacy of Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

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.

Inclusion Criteria:

1. Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
2. Hill's grade II and III of the gastroesophageal junction
3. One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH < 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of < 6mmHg or total length of less than 4cm or abdominal length of less than 2cm

Exclusion Criteria:

1. Age > 70 yrs of < 18 yrs
2. Pregnancy
3. Any type of Hiatus hernia
4. Patients with underlying malignancy
5. ASA above grade III