ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations
ACHAT-STUDY: Argon-Beamer-Ablation of Cervical Heterotopic Gastral Mucosa, an Alternative Treatment of Chronic Globus Sensations - "Sham-Controlled" Multicenter Study
1 other identifier
interventional
40
1 country
1
Brief Summary
Globus sensations are associated with gastroesophageal reflux disease as well as the presence of a gastric inlet patch. No controlled trial exists on whether ablation of the cervical heterotopic mucosa may lead to improvement of chronic globus sensations. The aim of this sham-controlled trial is to clarify whether argon-beamer-ablation of cervical heterotopic gastric inlet patches of the esophagus improves patients' chronic globus sensations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 21, 2007
CompletedFirst Posted
Study publicly available on registry
February 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 20, 2008
May 1, 2008
1.6 years
February 21, 2007
May 19, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months
Study Arms (2)
A
SHAM COMPARATORSham Procedure
B
ACTIVE COMPARATORVerum Beamer ablation of heterotopic gastric mucosa
Interventions
APC-Beamerablation of heterotopic gastric mucosa
Eligibility Criteria
You may qualify if:
- Globus sensations and histologically verified heterotopic gastric mucosa of the cervical esophagus
You may not qualify if:
- Malignancy in the ear, nose, and throat (ENT)-field
- Scleroderma
- Mental disability affecting a patient's ability to sign an informed consent document
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
II. Medical Department, Technical University Munich
Munich, Bavaria, 81675, Germany
Related Publications (1)
Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Hofler H, Prinz C, Schmid RM. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70. doi: 10.1055/s-2006-925362.
PMID: 16802267BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Meining, MD
II. Medical Department, TU-Munich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 21, 2007
First Posted
February 23, 2007
Study Start
October 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 20, 2008
Record last verified: 2008-05