NCT00954070|Terminated
Study Stopped
Difficulty in recruiting subjects for study
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Difficulty in recruiting subjects for study
Sponsor study identifier
observational
6
1 country
1
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)This is an observational, prospective and pilot study to determine through confocal endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of patients with non-erosive gastroesophageal reflux disease. The hypothesis is that minimal mucosal changes occur in non-erosive gastroesophageal reflux disease. Although these minimal changes are not always visible on white-light endoscopy, it is detectable using high-resolution confocal endomicroscopy and these confocal features are diagnostic of non-erosive reflux disease (NERD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 8, 2009
Actual (reported)August 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 6, 2009
Actual (reported)April 2012
Actual (reported)April 2012
Actual (reported)Specific microscopic changes in the esophageal mucosa as seen under the confocal endomicroscope
After 4 weeks phamacological washout period
The investigators cases are subjects with confirmed NERD and include male or female patients aged between 21 and 65 years, who present with typical clinical manifestations of gastroesophageal reflux and have no esophageal mucosal breaks upon conventional white-light endoscopy examination but show evidence of pathologic gastroesophageal reflux on 24-hr pH monitoring.
Healthy individuals aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases
The intervention is an endoscopy procedure using a novel type of endoscope with a powerful confocal microscope attached to its tip. The endoscope (Pentax Model EC3870K) provides both white-light and confocal microscopic imaging.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hosipital patients with typical clinical manifestations of gastroesophageal reflux disease but no endoscopy evidence of esophagitis.
National University Hospital
Singapore, 119074, Singapore
Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. doi: 10.1053/j.gastro.2004.08.014.
Calabrese C, Fabbri A, Bortolotti M, Cenacchi G, Areni A, Scialpi C, Miglioli M, Di Febo G. Dilated intercellular spaces as a marker of oesophageal damage: comparative results in gastro-oesophageal reflux disease with or without bile reflux. Aliment Pharmacol Ther. 2003 Sep 1;18(5):525-32. doi: 10.1046/j.1365-2036.2003.01713.x.
Khek Yu Ho, MD
National University Hospital, Singapore
6 participants (actual enrollment reported by the registry).
First Submitted
July 8, 2009
First Posted
August 6, 2009
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Ravelli AM, Villanacci V, Ruzzenenti N, Grigolato P, Tobanelli P, Klersy C, Rindi G. Dilated intercellular spaces: a major morphological feature of esophagitis. J Pediatr Gastroenterol Nutr. 2006 May;42(5):510-5. doi: 10.1097/01.mpg.0000215312.78664.b9.
Caviglia R, Ribolsi M, Gentile M, Rabitti C, Emerenziani S, Guarino MP, Petitti T, Cicala M. Dilated intercellular spaces and acid reflux at the distal and proximal oesophagus in patients with non-erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007 Mar 1;25(5):629-36. doi: 10.1111/j.1365-2036.2006.03237.x.
Caviglia R, Ribolsi M, Maggiano N, Gabbrielli AM, Emerenziani S, Guarino MP, Carotti S, Habib FI, Rabitti C, Cicala M. Dilated intercellular spaces of esophageal epithelium in nonerosive reflux disease patients with physiological esophageal acid exposure. Am J Gastroenterol. 2005 Mar;100(3):543-8. doi: 10.1111/j.1572-0241.2005.40978.x.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
December 28, 2012
Record last verified: 2012-12
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Source: ClinicalTrials.gov.
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