Efficacy and safety of ARM-P (Anti-reflux mucoplasty)

Efficacy and safety of ARM-P (Anti-reflux mucoplasty) for drug-resistant and dependent gastroesophageal reflux disease (GERD)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030230228

Enrollment

Registered

2023-07-14

Start date

2023-07-14

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

Drug-resistant/dependent gastroesophageal reflux disease (GERD) gastroesophageal reflux disease

Interventions

Artificial ulcers formed by performing ARMS close immediately after the procedure.

wound closure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study will include patients with drug-resistant/dependent gastroesophageal reflux disease (GERD) who meet the following indication criteria 1. Individuals who are scheduled for treatment with anti-reflux mucosal ablation (ARMS). 2. Individuals who have provided written consent to participate in this study. In the case of individuals under 18 years of age, written consent from a legal representative is also required.

Exclusion criteria

Exclusion criteria: 1. Individuals with significant sliding-type hiatal hernia. 2. Individuals with impaired esophageal motility. 3. Pregnant individuals. 4. Individuals with psychiatric or neurological disorders. 5. Individuals with severe respiratory diseases (such as chronic obstructive pulmonary disease, hypoxemia, home oxygen therapy, etc.). 6. Individuals with severe underlying conditions (severe heart failure, renal failure, liver failure). 7. Any other individuals deemed inappropriate for participation by the principal investigator or co-investigators.

Design outcomes

Primary

Measure	Time frame
Treatment success or failure (presence or absence of PPI/PCAB medication intake after treatment). Adverse events: bleeding, perforation, postoperative stenosis, etc.	—

Secondary

Measure	Time frame
Self-reported symptom scores (F scale, GERD-Q, GERD-HRQL, SF-36, Pittsburgh Sleep Quality Index). Key parameters of 24-hour esophageal pH monitoring (acid exposure time, DeMeester composite score, number of acid exposures, all reflux episodes, symptom index, symptom-associated probability). Endoscopic findings at 2-3 months and 1-3 years after treatment. Key parameters of 24-hour esophageal pH monitoring at 1-3 years after treatment. Self-reported symptom scores at 1-3 years after treatment (F scale questionnaire, GERD-Q score, GERD-HRQL, SF-36, Pittsburgh Sleep Quality Index). Evaluation using EPSIS before and after treatment.	—

Measure

Time frame

Self-reported symptom scores (F scale, GERD-Q, GERD-HRQL, SF-36, Pittsburgh Sleep Quality Index). Key parameters of 24-hour esophageal pH monitoring (acid exposure time, DeMeester composite score, number of acid exposures, all reflux episodes, symptom index, symptom-associated probability). Endoscopic findings at 2-3 months and 1-3 years after treatment. Key parameters of 24-hour esophageal pH monitoring at 1-3 years after treatment. Self-reported symptom scores at 1-3 years after treatment (F scale questionnaire, GERD-Q score, GERD-HRQL, SF-36, Pittsburgh Sleep Quality Index). Evaluation using EPSIS before and after treatment.

—

Contacts

Public ContactKazuki Yamamoto

Showa University Koto Toyosu Hospital

kazuki.yamamoto1102@gmail.com+81-3-6204-6000

Outcome results

None listed

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