NCT01324791

Brief Summary

Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

First QC Date

March 26, 2011

Last Update Submit

March 28, 2011

Conditions

Gastroesophageal Reflux Disease

Study Arms (2)

laparoscopic antireflux surgery

ACTIVE COMPARATOR
Procedure: anti-reflux surgery

endoscopic full-thickness-gastroplication

ACTIVE COMPARATOR
Procedure: anti-reflux surgery

Interventions

anti-reflux surgeryPROCEDURE
endoscopic full-thickness-gastroplicationlaparoscopic antireflux surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • long history of GERD symptoms
  • persistent or recurrent symptoms despite optimal medical treatment
  • persistent or recurrent complications of GERD
  • reduced quality of life owing to increasing esophageal exposure to gastric juice
  • pathological values in the preoperative evaluated functional parameters.

You may not qualify if:

  • any distinct hiatal hernia detectable by gastroscopy or barium radiography
  • dysphagia
  • esophageal strictures
  • poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GPH Zell am See

Zell am See, Salzburg, 5700, Austria

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2011

First Posted

March 29, 2011

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

AU(1)