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

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ClinicalTrials.gov Identifier: NCT01574755
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Tracking Information
First Submitted Date April 6, 2012
First Posted Date April 10, 2012
Last Update Posted Date July 2, 2013
Study Start Date September 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2013)
Change of globus complaint score [ Time Frame: retrospectively assessed: before APC therapy and at the date of follow up ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations
Official Title Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
biopsy of gastric inlet patches
Sampling Method Non-Probability Sample
Study Population outpatient clinic of a university hospital
Condition Globus Sensations in the Throat
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 16, 2012)
49
Original Actual Enrollment
 (submitted: April 9, 2012)
47
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01574755
Other Study ID Numbers ACHAT-FU-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Technische Universität München
Study Sponsor Technische Universität München
Collaborators Not Provided
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
PRS Account Technische Universität München
Verification Date June 2013