Prospective 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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798212

Enrollment

Registered

2013-02-25

Start date

2013-08-31

Completion date

2016-12-31

Last updated

2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

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

Interventions

PROCEDUREendoscopic full thickness plication

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026