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

Krankenhaus Barmherzige Schwestern Linz

Status

Completed

Conditions

Gastroesophageal Reflux Disease

Treatments

Procedure: endoscopic full thickness plication

Study type

Interventional

Funder types

Other

Identifiers

NCT01798212

PlicatorLinz

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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