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Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Enrolling

Conditions

Gastro Esophageal Reflux

Treatments

Procedure: Antireflux Mucosectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04194723
CREC 2016.194T

Details and patient eligibility

About

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

Full description

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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Antireflux Mucosectomy
Experimental group
Description:
Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction
Treatment:
Procedure: Antireflux Mucosectomy

Trial contacts and locations

1

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Central trial contact

Man Yee Yung; Philip Wai Yan Chiu, MD, FRCSEd

Data sourced from clinicaltrials.gov

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