Long Term Outcome of Argon Plasma Coagulation of Cervical... | NCT01574755

Studies
Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations

NCT01574755

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Jul 2, 2013Estimated

Enrollment

49Actual

Phase

Not provided

Conditions

Globus Sensations in the Throat

Interventions

Not provided

Countries

Not provided

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

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Apr 6, 2012

First Submission Date that Met QC Criteria

Apr 9, 2012

First Posted Date

Apr 10, 2012Estimated

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

Jun 29, 2013

Last Update Posted Date

Jul 2, 2013Estimated

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

APC of gastric inlet patches is successful for the treatment of globus sensations in the throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term efficiency of this treatment. To measure long term efficacy all patients treated with this therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.

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

Retention

Enrollment

49Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of globus complaint score		retrospectively assessed: before APC therapy and at the date of follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

former APC therapy of gastric inlet patches as treatment for globus sensations
at least 6 month since last APC therapy

Exclusion Criteria:

patients with reduced general condition
malignancy of the upper gastrointestinal tract
patients older than 80 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

outpatient clinic of a university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Klare, MD	Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany	Principal Investigator
Alexander Meining, Professor	Department for Internal Medicine and Gastroenterology, Technical University Munich, Germany	Study Chair
Monther Bajbouj, Assistent Professor	Department for Internal Medicine and Gastroenterology, Technical University Munich, Germany	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000079564	Globus Sensation

Ancestor Terms

ID	Term
D003291	Conversion Disorder
D013001	Somatoform Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

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