Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations (ACHAT FU)

June 29, 2013 updated by: Technical University of Munich
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

49

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

outpatient clinic of a university hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

July 2, 2013

Last Update Submitted That Met QC Criteria

June 29, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACHAT-FU-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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