Back to resultsProspective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
endoscopic full thickness plication
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Krankenhaus Barmherzige Schwestern
- Krankenhaus Zell am See
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
full thickness gastroplication
Arm Description
Outcomes
Primary Outcome Measures
Quality of Life using the Gastrointestinal Quality of Life Index
Secondary Outcome Measures
lower esophageal sphincter pressure using oesophageal manometry
DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment
Full Information
NCT ID
NCT01798212
First Posted
February 18, 2013
Last Updated
February 28, 2017
Sponsor
Krankenhaus Barmherzige Schwestern Linz
1. Study Identification
Unique Protocol Identification Number
NCT01798212
Brief Title
Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
Official Title
A Prospective Multi Center Case Controlled Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krankenhaus Barmherzige Schwestern Linz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
full thickness gastroplication
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
endoscopic full thickness plication
Other Intervention Name(s)
GERDx™
Primary Outcome Measure Information:
Title
Quality of Life using the Gastrointestinal Quality of Life Index
Time Frame
change from baseline in Quality of Life at 3 months, one year and three years after the intervation
Secondary Outcome Measure Information:
Title
lower esophageal sphincter pressure using oesophageal manometry
Time Frame
change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion
Title
DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment
Time Frame
change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Krankenhaus Barmherzige Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Krankenhaus Zell am See
City
Zell am See
ZIP/Postal Code
5700
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
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