Status:
NOT_YET_RECRUITING
Endoscopic Cardial Constriction Ligation (ECCL) for Refractory GERD Using a Disposable Endoscope
Lead Sponsor:
Ying Zhu
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will recruit patients aged 18-80 with refractory gastroesophageal reflux disease (GERD). These patients had a disease course of more than six months, experienced typical symptoms such as ac...
Detailed Description
Gastroesophageal reflux disease (GERD) is a common digestive disorder, with endoscopic manifestations including non-erosive reflux disease (NERD), reflux esophagitis (RE), and Barrett's esophagus (BE)...
Eligibility Criteria
Inclusion
- (1) Age 18-80 years;
- (2) Disease duration ≥6 months, with typical symptoms such as acid regurgitation and heartburn, and a confirmed diagnosis of GERD;
- (3) GERD patients whose symptoms are not relieved after 8 weeks of continuous double-dose acid-suppressive therapy;
- (4) Willing to participate in the study and have signed the informed consent form.
Exclusion
- (1) Patients with precancerous lesions such as early esophageal cancer or Barrett's esophagus \>3 cm, or advanced upper gastrointestinal cancer identified on endoscopy;
- (2) Patients with hiatal hernia ≥2 cm, severe reflux esophagitis (LA-C or LA-D grade), esophageal or gastric varices, esophageal ulcer or stenosis, or a history of esophageal or gastric surgery;
- (3) Patients with esophageal motility disorders such as achalasia or diffuse esophageal spasm, rheumatic diseases such as systemic sclerosis or Sjögren's syndrome, or eosinophilic esophagitis;
- (4) Patients with a history of endoscopic or surgical anti-reflux procedures;
- (5) Patients with coagulation disorders, severe cardiopulmonary diseases, or inability to tolerate anesthesia, endoscopy, or treatment;
- (6) Women in the puerperium.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT07176221
Start Date
October 1 2025
End Date
June 30 2028
Last Update
September 16 2025
Active Locations (1)
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1
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China, 510515