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

Gastroesophageal Reflux Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798212
• Other study ID #: PlicatorLinz
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: February 28, 2017
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• endoscopic full thickness plication

Locations

Country	Name	City	State
Austria	Krankenhaus Barmherzige Schwestern	Linz
Austria	Krankenhaus Zell am See	Zell am See

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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