Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

Study Overview
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Brief Summary
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This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.

Detailed Description
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The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.

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

Conditions
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Gastro Esophageal Reflux

Intervention / Treatment
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* Procedure: Antireflux Mucosectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months Hill's grade II and III of the gastroesophageal junction 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: Age > 70 yrs of < 18 yrs Pregnancy Any type of Hiatus hernia Patients with underlying malignancy ASA above grade III

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antireflux Mucosectomy<br>Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction | Procedure: Antireflux Mucosectomy<br>* ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Success in resection of mucosa at cardia by ARMS | 1 day | 
| 24 hour pH study post ARMS | 24 hour pH study | 3 and 12 months | 
| High resolution Manometry | HRM | 3 and 12 months | 
| Gastroesophageal junction classified by Hill's classification | endoscopic assessment of Gastroesophageal junction | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antireflux Mucosectomy, GERD