Determinants of Efficacy of EsophyX Treatment in Gastro-E... | NCT00498082

Studies
Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease

NCT00498082

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Sep 6, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease

Interventions

Not provided

Countries

Belgium

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

Sep 2007

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

Sep 2007

Primary Completion Date

Not provided

Completion Date

Sep 2008Estimated

First Submitted Date

Jul 6, 2007

First Submission Date that Met QC Criteria

Jul 6, 2007

First Posted Date

Jul 9, 2007Estimated

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

Sep 5, 2007

Last Update Posted Date

Sep 6, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

EsophyX is a promising endoscopic treatment for gastro-esophageal reflux disease. It is not known whether there are some pre- or per-operative anatomic or pathophysiological findings which may influence outcome.

The aim of this trial is to study a series of parameters acquired during the pre-therapeutic work-up or during the procedure and their influence on the outcome of the procedure.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients being considered for EsophyX treatment of GERD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hubert Piessevaux, MD, PhD	Contact	+ 32 2 764 28 34		piessevaux@gaen.ucl.ac.be

Overall Officials

Name	Affiliation	Role
Hubert Piessevaux, MD, PhD	Cliniques universitaires St-Luc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires St-Luc	Recruiting	Brussels		1200	Belgium

Label	URL
Cliniques universitaires St-Luc	View source

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided