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Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)

Department of Gastroenterology, Zhongda Hospital

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03259191
Enrollment
20
Registered
2017-08-23
Start date
2017-08-20
Completion date
2020-08-31
Last updated
2017-08-23

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

Conditions

Refractory Gastroesophageal Reflux Disease

Keywords

Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy

Brief summary

Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.

Interventions

PROCEDUREanti-reflux mucosectomy

Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.

Sponsors

Ruihua Shi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Full sufficiency in literacy 2. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks 3. Refractory gastroesophageal reflux disease

Exclusion criteria

1. Severe heart, lung, and cerebrovascular disease 2. Severe hematopoietic system disease 3. Abnormal blood coagulation function 4. Oropharyngeal abnormalities 5. Severe spine malformation 6. In pregnancy and lactation at present, or plan to become pregnant within 2 years 7. Severe inflammation or huge ulcers in stomach 8. Mental and psychological disorde

Design outcomes

Primary

MeasureTime frameDescription
Improvement of symptoms1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 monthsImprovement of all the symptoms related with RGERD.

Secondary

MeasureTime frameDescription
Complications of ARMS1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 monthsComplications of ARMS,such as esophageal stenosis and dysphagia.

Countries

China

Contacts

Primary ContactRuihua Shi, MD,PhD
ruihuashi@126.com+8613951799326
Backup ContactJiacheng Tan, MD,PhD
cencen_njjs@126.com+8615105165989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026