- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439439
ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations
May 19, 2008 updated by: Technical University of Munich
ACHAT-STUDY: Argon-Beamer-Ablation of Cervical Heterotopic Gastral Mucosa, an Alternative Treatment of Chronic Globus Sensations - "Sham-Controlled" Multicenter Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Some data suggest that ablation of gastric inlet patches by argon beamer therapy might lead to alleviation of chronic globus sensation or sore throat.
Acid reflux or its treatment is unlikely to influence these results (Meining et al.
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).
Within the present study we will perform a randomized, sham-controlled and blinded trial, where patients with heterotopic gastric mucosa (HGM) of the cervical esophagus and globus sensations (a chronic or intermittent lump in the throat for at least 3 months) are going to be randomized after histological verification of HGM in the study center (Technical University Clinic Munich).
Either a beamer ablation of HGM or a sham-therapy will be performed after patients complete a validated questionnaire.
Patients are blinded for 3 months, then after completing another questionnaire endoscopy is repeated.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 81675
- II. Medical Department, Technical University Munich
-
-
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
Description
Inclusion Criteria:
- Globus sensations and histologically verified heterotopic gastric mucosa of the cervical esophagus
Exclusion Criteria:
- Malignancy in the ear, nose, and throat (ENT)-field
- Scleroderma
- Mental disability affecting a patient's ability to sign an informed consent document
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: A
Sham Procedure
|
APC-Beamerablation of heterotopic gastric mucosa
|
Active Comparator: B
Verum Beamer ablation of heterotopic gastric mucosa
|
APC-Beamerablation of heterotopic gastric mucosa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander Meining, MD, II. Medical Department, TU-Munich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
February 21, 2007
First Submitted That Met QC Criteria
February 21, 2007
First Posted (Estimate)
February 23, 2007
Study Record Updates
Last Update Posted (Estimate)
May 20, 2008
Last Update Submitted That Met QC Criteria
May 19, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1427/05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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