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

NCT01798212 | Completed DMC

• 1 other identifier: PlicatorLinz
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

• 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

Study Arms (1)

full thickness gastroplication

OTHER

Procedure: endoscopic full thickness plication

Interventions

endoscopic full thickness plication PROCEDURE

Also known as: GERDx™

full thickness gastroplication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Krankenhaus Barmherzige Schwestern Linz: lead

Study Sites (2)

Krankenhaus Barmherzige Schwestern

Linz, 4010, Austria

Location

Krankenhaus Zell am See

Zell am See, 5700, Austria

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 25, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

AU (2)