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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798212
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Barmherzige Schwestern Linz

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
Gastroesophageal Reflux Disease Procedure: endoscopic full thickness plication Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
full thickness gastroplication Procedure: endoscopic full thickness plication
Other Name: GERDx™




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798212


Locations
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Austria
Krankenhaus Barmherzige Schwestern
Linz, Austria, 4010
Krankenhaus Zell am See
Zell am See, Austria, 5700
Sponsors and Collaborators
Krankenhaus Barmherzige Schwestern Linz
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Responsible Party: Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT01798212    
Other Study ID Numbers: PlicatorLinz
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Krankenhaus Barmherzige Schwestern Linz:
GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases