Gastroesophageal Reflux
Conditions
Interventions
Intervention Group: Magnetic Sphincter Augmentation Device
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. To be diagnosed as gastroesophageal reflux disease, and need to have a written history no less than 6 months of GERD typical symptoms (abbreviated); 2. The physiological condition acceptable surgical treatment, such as tolerance to conventional anesthesia and endoscopic surgery; 3. Need to take daily PPI or other anti-reflux drug treatment of GERD symptoms; 4. 24 hours esophageal pH-impedance monitoring results: "pH <4 time" = 4.5%. (Subjects should discontinue anti-reflux medication for at least 7 days prior to the test); 5. Suspended anti-reflux drug treatment period (at least 7 days), with GERD symptoms; 6. GERD-HRQL score =10, GERD-HRQL score =15 during drug withdrawal, or GERD-HRQL score during drug withdrawal and drug withdrawal period, and there was significant improvement in symptoms after receiving anti-reflux drug therapy; The difference is = 6; 7. Aged 18-75 years and life expectancy is greater than 3 years; 8. male or female; 9. Women of childbearing age within one week before surgery to accept pregnancy and the results were negative, and must agree to take effective measures in the research cycle of birth control; 10. Clear that the current unwilling to accept fundoplication treatment (endoscopic or open surgery); 11. Willing to cooperate with the completion of the entire testing process and related checks; 12. Voluntary participation and written written informed consent.
Exclusion criteria
Exclusion criteria: 1. Infectious disease with systemic therapy indicated; 2. Body temperature of 38 degree C or more; 3. Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding; 4. Severe psychiatric disease; 5. Continuous systemic steroid or immune-suppressive drug therapy; 6. Unstable angina pectoris or history of myocardial infarction within 6 months; 7. Severe pulmonary fibrosis or emphysema; 8. Poorly controlled hypertension; 9. Poorly controlled diabetes mellitus in spite of continuous use of insulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality of life score; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24 hours PH; | — |
Countries
China
Contacts
Public ContactYifeng Sun
Shanghai Chest Hospital
Outcome results
None listed