GERD
Conditions
Interventions
experimental group:Magnetic Sphincter Augmentation
Sponsors
Shanghai Chest hospital
Eligibility
Sex/Gender
All
Age
10 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Age =18 and 3 years (2)Being able to receive surgery based on the physiological condition, e.g., capable of tolerating conventional anesthesia and laparoscopic surgery (3)A history of GERD for at least 6 months (including confirmed diagnosis or typical symptoms of GERD, such as acid regurgitation and heartburn, etc.), and response to drug acid neutralization or inhibition therapy (4)Requiring daily use of PPI (5)Total duration of acid exposure >4.5% in esophageal pH monitoring. (Before this examination, all the anti-acid reflux drugs should be discontinued for at least 7 days.) (6)Having symptoms of GERD during dose interruption of PPI (7)Being willing to cooperate with and complete study follow-up and relevant examinations (8)Being willing to participate in the study and sign the written informed consent form voluntarily
Exclusion criteria
Exclusion criteria: (1)Requiring emergency surgery (2)Having participated in the clinical trial on other investigational drugs or device in the past 3 months (3)Having one of the following histories: gastroesophageal surgery, anti-reflux surgery, a history of gastroesophageal cancer or gastric cancer (4)A history of endoscopic intervention for GERD or BE (5)Suspected or confirmed esophageal cancer or gastric cancer (6)Endoscopically confirmed esophageal hiatus hernia >2cm (7)Esophageal manometry: mean distal contraction integral (DCI) post throat wetting30% (8)Grade C or D esophagitis (LA classification criteria) (9)Body mass index (BMI) >35 (10)Having dysphagia for more than once a week on average in recent 3 months (11)Diagnosis of scleroderma (12)Diagnosis of esophageal motility disorder (e.g., achalasia, nutcracker esophagus, diffuse esophagism, lower esophageal sphincter hypertension, etc.) (13)Known esophageal stenosis or abnormal anatomical structure of esophagus (e.g., Schatzki’s ring, obstructive disorder, etc.), or having relevant history (14)Having esophageal or gastric varices (15)Having BE (16)Failure to understand the requirements in the trial, or complete study follow-up (17)Pregnant or lactating woman, or plan of childbearing during the study (18)Having a disease possibly leading to failure to meet the requirements in the protocol or low life expectancy (e.g., < 3 years) (e.g., congestive heart failure, etc.) (19)Diagnosis of mental disorder (e.g., bipolar disorder, schizophrenia, etc.), except the depression due to use of some drugs (20)Known or suspected allergy to titanium, stainless steel, nickel or iron-containing elements (21)Electronic implant in body, or metal implant in the abdomen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate of surgical treatment with Magnetic Sphincter Augmentation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Use of anti-reflux PPI;GerdQ questionnaire score; | — |
Countries
China
Contacts
Public ContactZhigang Li
Shanghai Chest hospital
Outcome results
None listed