Status:
COMPLETED
Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
Lead Sponsor:
Krankenhaus Barmherzige Schwestern Linz
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD. The primary objective of the present trial is ...
Eligibility Criteria
Inclusion
- Written informed consent; ≥ 18 years of age;
- GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following criteria:
- Total Number of Reflux Events ≥ 73/24h;
- DeMeester Score ≥ 14.7;
- Positive Symptom Index - SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks.
Exclusion
- Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction;
- ≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia \>2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification \>II
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01798212
Start Date
August 1 2013
End Date
December 1 2016
Last Update
March 1 2017
Active Locations (2)
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1
Krankenhaus Barmherzige Schwestern
Linz, Austria, 4010
2
Krankenhaus Zell am See
Zell am See, Austria, 5700