NCT03259191UnknownNot Applicable
Department of Gastroenterology, Zhongda Hospital
Ruihua Shi1 site in 1 country20 target enrollmentStarted: August 20, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement of symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Full sufficiency in literacy
- •Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
- •Refractory gastroesophageal reflux disease
Exclusion Criteria
- •Severe heart, lung, and cerebrovascular disease
- •Severe hematopoietic system disease
- •Abnormal blood coagulation function
- •Oropharyngeal abnormalities
- •Severe spine malformation
- •In pregnancy and lactation at present, or plan to become pregnant within 2 years
- •Severe inflammation or huge ulcers in stomach
- •Mental and psychological disorde
Arms & Interventions
completely circumferential ARMS
Other
Intervention: anti-reflux mucosectomy (Procedure)
semi-circumferential ARMS
Other
Intervention: anti-reflux mucosectomy (Procedure)
Outcomes
Primary Outcomes
Improvement of symptoms
Time Frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Improvement of all the symptoms related with RGERD.
Secondary Outcomes
- Complications of ARMS(1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months)
Investigators
Ruihua Shi
MD, PhD, Postdoctoral Mentor, Chief Physician
Zhongda Hospital
Study Sites (1)
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