Evaluation of the Medex Test for the Detection of Gastrointestinal Disorders

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The primary objective is to compare findings achieved by traditional diagnostic procedures with those of the MEDEXTEST in order to define specificity, sensitivity and accuracy of the MEDEXTEST device. Traditional diagnostic procedures include an evaluation by a physician (history and physical examination), Esophagogastroduodenoscopy (EGD) with/without biopsy and Urea Breath Test. The study population will include 200 male and female patients with clinical symptoms of gastroduodenal disorders of similar baseline characteristics (age, BMI and gender). Investigators and Gastroenterologists at Nepean Hospital will refer patients. Eligibility will be determined by satisfying the following inclusion and exclusion criteria. Eligible participants will undergo a baseline evaluation, which includes: written consent, demographic information, medical history, current medications and a physical examination. Participants will undergo the 20-minute MEDEXTEST conducted by a trained Research Assistant. They will be advised of their results at an appointment with their physician following their endodoscopy procedure. The participants will be referred to tests according to clinical and examination findings such as an Esophagogastroduodenoscopy (EGD) (with or without biopsy) and Urea Breath Test. The MEDEXTEST is a non-invasive examination lasting approximately 20 minutes in duration and performed in the following manner: - External measurement of the skin’s electrical resistance of 24 zones located on the participant’s feet and hands. - T.E.N.S stimulation. - A repeated measurement of the 24 zones. - Mathematical processing of the collected information by the help of a previously composed correlative algorithm. - The results will be saved in the operator’s computer memory and, additionally, a printout will be filed in the patient’s source documentation file. At the completion of data collection, a trained physician will make an independent reading from the MEDEXTEST results, with another physician diagnosing the participant based on the traditional procedures. To minimize the risk of bias, all physicians will be blind to their colleague’s diagnosis. A third investigator will compare the diagnosis from the traditional diagnostic procedures against the MEDEXTEST, record test results in participants’ CRF and conduct a follow-up consultation with participant. After the required data is obtained from all study participants of the study site, the results of the MEDEXTEST will be compared with the actual participant’s condition as indicated by the traditional tests, in order to determine the sensitivity, specificity and total accuracy of the device. The estimated duration of the study is 1 year including data analysis and reporting.

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