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

February 28, 2017 updated by: Krankenhaus Barmherzige Schwestern Linz

A Prospective Multi Center Case Controlled Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4010
        • Krankenhaus Barmherzige Schwestern
      • Zell am See, Austria, 5700
        • Krankenhaus Zell am See

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: full thickness gastroplication
Procedure: endoscopic full thickness plication
Other Names:
  • GERDx™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
change from baseline in Quality of Life at 3 months, one year and three years after the intervation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion
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
change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Barmherzige Schwestern Linz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (ESTIMATE)

February 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PlicatorLinz

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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