Status:
COMPLETED
Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
Gastro Esophageal Reflux Disease
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder with a significant proportion of patients becoming dependent on proton pump inhibitor (PPI) therapy. Long term use of PPI ...
Detailed Description
Patients screening and inclusion: The study will be conducted over 6-month period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD heal...
Eligibility Criteria
Inclusion
- Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI
- Patients who are willing to pay the expenses of the GERD-X procedure
Exclusion
- Large Hiatal hernia \>3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure \<5 or \>15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
- Esophageal dysmotility
- ASA physical status \>II
- Previous esophageal or gastric surgery
- Pregnancy
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03322553
Start Date
November 15 2017
End Date
December 30 2019
Last Update
January 22 2020
Active Locations (1)
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1
Asian institute of Gastroenterology
Hyderabad, Telangana, India, 500082