Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFar Eastern Memorial Hospital

About this trial

The goal of this randomized clinical trial is to investigate the efficacy and safety of antireflux mucosal ablation (ARMA) for patients with refractory gastroesophageal reflux disease (GERD). The trial aim to evaluate :

* Efficacy of ARMA comparing with medical treatment alone (proton pump inhibitor (PPI)), using GERD-Health Related Quality of Life Questionnaire (GERD- HRQL questionnaire), improvement of acid exposure time and DeMeester score * Safety and complications of ARMA Participants will be randomly divided into 2 groups. The intervention group will be undergone ARMA, and the control group will be undergone sham endoscopic treatment.

The primary endpoint will be symptoms relief (GERD-HRQL decreases \> 50%). The secondary endpoint will be dosage adjustment of PPI, complications, improvement of acid exposure time and DeMeester score.

Eligibility criteria

Qualifiers

Adults aged over 18 years old

History of GERD for over 6 months, who had received PPIs for over 6 months but still had symptoms of typical GERD symptoms (GERD-HRQL score of >8, acid reflux sensation or heartburn), and/or other symptoms as lump throat, night cough, acid related chest tightness (without other possible explanation of these symptoms)

Acid exposure time > 6%

DeMeester score ≥ 14.72

Disqualifiers

Pregnancy

BMI>=35

Hiatal hernia > 2cm or Flap Valve Hill grade III/IV

GERD LA grade C/D or esophageal ulcer

Trial design

Treatments tested in this trial

  • Antireflux mucosal ablation
  • Sham procedure

Treatment groups

68 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators