Full-Thickness-Gastroplication For The Treatment Of Gastr... | NCT01453985

Studies
Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD

NCT01453985

Sponsor

General Public Hospital Zell am See

Status

Unknown status

Last Update Posted

Oct 18, 2011Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Gastroesophageal Reflux Disease

Interventions

Full-Thickness-Gastroplication

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 12, 2011

First Submission Date that Met QC Criteria

Oct 14, 2011

First Posted Date

Oct 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2011

Last Update Posted Date

Oct 18, 2011Estimated

Description Module

Brief Summary

This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Full-Thickness-Gastroplication	Experimental		Procedure: Full-Thickness-Gastroplication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Full-Thickness-Gastroplication	Procedure		Full-Thickness-Gastroplication

Measure	Description	Time Frame
Quality of Life

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes >73.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rudolph Pointner, Prof.	Contact	004365427772210		ac.sekretariat@kh-zellamsee.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General public hospital Zell am See	Recruiting	Zell am See		5700	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23021166	Derived	Koch OO, Kaindlstorfer A, Antoniou SA, Spaun G, Pointner R, Swanstrom LL. Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants. Gastrointest Endosc. 2013 Jan;77(1):7-14. doi: 10.1016/j.gie.2012.07.033. Epub 2012 Sep 26.

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases