Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux (ARMS)

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.

Study Overview

• Status: Recruiting
• Conditions: Gastro Esophageal Reflux
• Intervention / Treatment: Procedure: Antireflux Mucosectomy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Wai Yan Chiu, MD, FRCSEd; Phone Number: +85235053952; Email: philipchiu@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Man Yee Yung; Phone Number: +85235052956; Email: myyung@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Recruiting
    • Combined Endoscopy Center, Prince of Wales Hospital
    • Contact: Man Yee Yung; Phone Number: +85235052956; Email: myyung@surgery.cuhk.edu.hk
    • Contact: Philip Chiu, MD; Phone Number: 85226322627; Email: philipchiu@surgery.cuhk.edu.hk
    • Principal Investigator: Philip WY Chiu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antireflux Mucosectomy; 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; ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: GERD; Antireflux Mucosectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: CREC 2016.194T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No