Status:
UNKNOWN
A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux
Lead Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Collaborating Sponsors:
Beijing 302 Hospital
Beijing Hospital
Conditions:
GERD
Reflux Esophagitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. In the study, the inve...
Detailed Description
Gastroesophageal reflux disease (GERD) is a neuromuscular disorder with abnormal reflux of gastric contents into the esophagus.The most common symptoms are heartburn, dysphagia, and regurgitation.Due ...
Eligibility Criteria
Inclusion
- Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
- Patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease
- Pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour pH-monitoring with \> 5% of time a pH \< 4 and a symptom-association probability \> 95%
- written informed consent
Exclusion
- 24 hr acid exposure study showing abnormal esophageal acid exposure \<4%
- DeMeester Score \<14.7
- hiatal hernia (\> 3 cm in length)
- history of antireflux or esophageal/gastric surgery
- severe psychiatric disease
- Barrett's esophagus with dysplasia
- esophageal stenosis/malignancy
- pregnancy or lactation
- history of low therapeutic compliance
- other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder)
- use of anticoagulant or immunosuppressive drugs
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05192538
Start Date
February 10 2022
End Date
May 1 2022
Last Update
March 16 2022
Active Locations (1)
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1
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100071