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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04194723

Acronym

ARMS

Enrollment

Registered

2019-12-11

Start date

2018-01-01

Completion date

2024-12-31

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Esophageal Reflux

Keywords

Antireflux Mucosectomy, GERD

Brief summary

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

Detailed description

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

Interventions

PROCEDUREAntireflux Mucosectomy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement in Gastro Esophageal Reflux symptoms	3 months	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

Secondary

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

Countries

Hong Kong

Contacts

Primary ContactPhilip Wai Yan Chiu, MD, FRCSEd

philipchiu@surgery.cuhk.edu.hk+85235053952

Backup ContactMan Yee Yung

myyung@surgery.cuhk.edu.hk+85235052956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026