| February 21, 2007 |
| May 19, 2008 |
| October 2006 |
| May 2008 (final data collection date for primary outcome measure) |
| outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months |
| Same as current |
| Complete list of historical versions of study NCT00439439 on ClinicalTrials.gov Archive Site |
| |
| |
| |
| 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 |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study |
- Globus
- Deglutition Disorders
|
| Radiation: Beamer Ablation (Argon Plasma Coagulation) |
- Sham Comparator: Sham Procedure
- Active Comparator: Verum Beamer ablation of heterotopic gastric mucosa
|
| 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. |
| |
| Completed |
| 40 |
| May 2008 |
| May 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00439439 |
| II: Medizinische Klinik, Technische Universität München |
| 1427/05 |
| Technische Universität München |
|
| Principal Investigator: |
Alexander Meining, MD |
II. Medical Department, TU-Munich |
|
|
| Technische Universität München |
| May 2008 |
