Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

Gastro Esophageal Reflux Clinical Trial

— ARMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194723
• Other study ID #: CREC 2016.194T
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Philip Wai Yan Chiu, MD, FRCSEd
• Phone: +85235053952
• Email: philipchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Procedure:
• Antireflux Mucosectomy
ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux

Locations

Country	Name	City	State
Hong Kong	Combined Endoscopy Center, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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