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Efficacy and safety of Anti-reflux mucosal ablation for refractory GERD: Multi-center prospective study.

Efficacy and safety of Anti-reflux mucosal ablation for refractory GERD: Multi-center prospective study. - Efficacy and safety of ARMA for GERD: Multi-center prospective study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045188
Enrollment
100
Registered
2021-08-18
Start date
2021-08-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

PPI/PCAB refractory/dependent GERD

Interventions

Place sub-circumferential endoscopic ablation at the gastric cardia utilizing Argon plasma coagulation(APC).

Sponsors

Showa University Koto Toyosu Hospital, Digestive Diseases Center
Lead Sponsor
Fukuoka University Hospital Tottori University Hospital Osaka City University Hospital Aichi Medical University Hospital Shinshu University Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient with PPI/PCAB refractory/dependent GERD.

Exclusion criteria

Exclusion criteria: Inability or unwillingness of patients to give written informed consent. Patient with prominent sliding hernia. Patient with impaired esophageal motility. Pregnancy. Patient with psychiatric/Neurological disorders. Patient with severe comorbidities. Judged unsuitable for this study by the physicians

Design outcomes

Primary

MeasureTime frame
Symptom scores(F scale,GERD-Q,GERD-HRQL,SF-36, Pittsburgh sleep quality index)

Secondary

MeasureTime frame
24h pH monitoring(Acid Exposure Time, DeMeester Composite Score, Number of acid exposure, All reflux episode, Symptom Index, Symptom Associated Possibility) Endoscopic image (after 1-3 years) 24h pH monitoring (after 1-3 years) Necessity of PPI/PCAB EPSIS before and after ARMA Adverse event: incidence of bleeding, perforation, stenosis

Countries

Japan

Contacts

Public ContactMayo Tanabe

Showa University Koto Toyosu Hospital Digestive Diseases Center

mayo.tanabe@gmail.com+81362046000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026