Non-invasive device for diagnosing gastroesphageal reflux
a gastroesophageal reflux and non-invasive technology, applied in the field of gastroesophageal reflux diagnosis and management, can solve the problems of exacerbated reflux, difficult detection of reflux and related symptoms, and few properly designed prospective studies, at least in infants, to achieve accurate, quantitative, and non-invasive diagnosis
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example i
Capturing a Reflux Event
[0121]The following describes exemplary compositions and methods for providing a system for capturing, measuring, analyzing and identifying a reflux event. This example describes collecting exemplary reflux events in preterm infant patients and term infant patients.
[0122]The inventors captured sub-audible signals originating in the area of the lower esophageal sphincter, i.e. a reflux event, by capturing acoustic signals from an externally placed Sensotec accelerometer model #MAQ36 (Honeywell, Inc., Columbus, Ohio) that in separate experiments was either placed on the skin of the patient's anterior thoracic cage just to the right (baby's left) of the xiphoid process (i.e., between the sub-xiphoid process and the thoracic inlet (see, FIG. 1Aa), as shown in this Example, or placed on a patient's back in subsequent experiments (see, FIG. 1Ab). The inventors substituted a posterior location due to the discovery that a stronger signal was obtained from the back se...
example ii
The Following Example Demonstrates an Added Benefit of Using Compositions and Methods of the Present Inventions for Identifying a Reflux Event
[0128]The following describes an exemplary comparison between pH probe data and accelerometric data of the present inventions. The compositions and methods of the present inventions were essentially those described in Example I. The compositions and methods of using a pH probe were standard for reflux patients, an example is provided in Pezzati, et al., Neonatology. 2007;91(3):162-6. Epub 2006 Nov 29 and Lopez-Alonso, et al., Pediatrics. 2006 Aug;118(2):e299-308. Epub 2006 Jul 10; all of which are herein incorporated by reference in their entirety.
[0129]In particular, this comparison shows that positive accelerometric readings (an identification of a reflux event) occurred (upper area of FIG. 4) when pH probes demonstrated the “gold standard” acid reflux event (lower area of FIG. 4).
[0130]Further, another comparison (in a different patient) sh...
example iii
[0131]This Example describes an exemplary quantitative analysis for a “GERDodometer” of the present inventions (Gewolb and Vice, poster, Pediatric Academic Societies meeting, May 2009).
[0132]In this Example, a preliminary correlative analysis was made for acid reflux and nonacid reflux events between pH and a preliminary grading system designed by the inventors. Information for this comparison was obtained from 30 ex-preterm neonates undergoing pH monitoring (internal pH probe recordings) and external monitoring using a system of the present inventions. Specifically, an accelerometer was taped to the skin over the sub-xiphoid process and / or the caudal thorax of 30 ex-preterm neonates. Signals were step-amplified to a digital recorder (sample rate 250 Hz), which captured low-frequency, sub-audible reflux-associated signals. Fast Fourier Transforms (FFTs) graphically displayed the Hz and amplitude (as described and shown herein). At least 1000 4 minute aliquots were graded and scored ...
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