Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Gastro Esophageal Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antireflux Mucosectomy

Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction

Group Type EXPERIMENTAL

Antireflux Mucosectomy

Intervention Type PROCEDURE

ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux

Interventions

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Antireflux Mucosectomy

ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux

Intervention Type PROCEDURE

Eligibility Criteria

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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