Clincosm LogoSign in Get a demo

Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

Sponsor
Krankenhaus Barmherzige Schwestern Linz (Other)
Overall Status
Completed
CT.gov ID
NCT01798212
Collaborator
(none)
40
Enrollment
2
Locations
1
Arm
40
Duration (Months)
20
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: endoscopic full thickness plication
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: full thickness gastroplication

Procedure: endoscopic full thickness plication
Other Names:
  • GERDx™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life using the Gastrointestinal Quality of Life Index [change from baseline in Quality of Life at 3 months, one year and three years after the intervation]

    Secondary Outcome Measures

    1. lower esophageal sphincter pressure using oesophageal manometry [change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion]

    2. DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment [change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Krankenhaus Barmherzige Schwestern Linz Austria 4010
    2 Krankenhaus Zell am See Zell am See Austria 5700

    Sponsors and Collaborators

    • Krankenhaus Barmherzige Schwestern Linz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Krankenhaus Barmherzige Schwestern Linz
    ClinicalTrials.gov Identifier:
    NCT01798212
    Other Study ID Numbers:
    • PlicatorLinz
    First Posted:
    Feb 25, 2013
    Last Update Posted:
    Mar 1, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Krankenhaus Barmherzige Schwestern Linz
    GERD
    Additional relevant MeSH terms:
    Gastroesophageal Reflux

    Study Results

    No Results Posted as of Mar 1, 2017