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

Phase 1

• Conditions: Drug-resistant/dependent gastroesophageal reflux disease (GERD); gastroesophageal reflux disease

• Registration Number: JPRN-jRCT1030230228
• Lead Sponsor: Yamamoto Kazuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 93

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success or failure (presence or absence of PPI/PCAB medication intake after treatment).<br>Adverse events: bleeding, perforation, postoperative stenosis, etc.

Secondary Outcome Measures

Name	Time	Method
Self-reported symptom scores (F scale, GERD-Q, GERD-HRQL, SF-36, Pittsburgh Sleep Quality Index).<br>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).<br>Endoscopic findings at 2-3 months and 1-3 years after treatment.<br>Key parameters of 24-hour esophageal pH monitoring at 1-3 years after treatment.<br>Self-reported symptom scores at 1-3 years after treatment (F scale questionnaire, GERD-Q score, GERD-HRQL, SF-36, Pittsburgh Sleep Quality Index).<br>Evaluation using EPSIS before and after treatment.