Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12606000338561
Ethics application status
Approved
Date submitted
26/07/2006
Date registered
8/08/2006
Date last updated
8/08/2006
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of the Medex Test for the Detection of Gastrointestinal Disorders
Query!
Scientific title
Evaluation of the Medex Test for the Detection of Gastrointestinal Disorders
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Disorders
1311
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
1398
1398
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The MEDEXTEST device is intended to differentiate between normal and abnormal function of the stomach and duodenum. The MEDEXTEST is a non-invasive radiation free device. The examination lasts approximately 20 minutes and is performed in the following manner:
1. External measurement of 24 skin zones located on the limbs.
2. Stimulation of four special skin zones – lasting one minutes each.
3. External measurement of the same 24 zones.
The study design is blind, one-armed, comparative, prospective and without a control group. The examination is only conducted once.
Query!
Intervention code [1]
1230
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
1911
0
The primary objective is to determine the sensitivity of the device through it’s ability to accurately and effectively diagnose:
1. Disorders of the stomach and duodenum due to Gastritis, Gastroduodenitis, Peptic Ulcer Disease, Gastric Cancer and other causes.
2. Type of disease
Assuming true sensitivity and specificity of 0.90, the criteria for the study success will be observing sensitivity and specificity of above 0.80 at a confidence interval of 97.5.
Query!
Assessment method [1]
1911
0
Query!
Timepoint [1]
1911
0
Measured and evaluated at the completion of the MEDEXTEST and other investigations (EGD with or without biopsy and Urea Breath Test) on all 200 study participants.
Query!
Primary outcome [2]
1912
0
The primary objective is to determine the specificity of the device through it’s ability to accurately and effectively diagnose:
1. Disorders of the stomach and duodenum due to Gastritis, Gastroduodenitis, Peptic Ulcer Disease, Gastric Cancer and other causes.
2. Type of disease
Assuming true sensitivity and specificity of 0.90, the criteria for the study success will be observing sensitivity and specificity of above 0.80 at a confidence interval of 97.5.
Query!
Assessment method [2]
1912
0
Query!
Timepoint [2]
1912
0
Query!
Primary outcome [3]
1913
0
The primary objective is to determine the total accuracy of the device through it’s ability to accurately and effectively diagnose:
1. Disorders of the stomach and duodenum due to Gastritis, Gastroduodenitis, Peptic Ulcer Disease, Gastric Cancer and other causes.
2. Type of disease
Assuming true sensitivity and specificity of 0.90, the criteria for the study success will be observing sensitivity and specificity of above 0.80 at a confidence interval of 97.5.
Query!
Assessment method [3]
1913
0
Query!
Timepoint [3]
1913
0
Query!
Secondary outcome [1]
3369
0
The secondary objective is to evaluate the technical intra-device variability between Medex Test devices.
Query!
Assessment method [1]
3369
0
Query!
Timepoint [1]
3369
0
Query!
Secondary outcome [2]
3370
0
The observed sensitivity and specificity of the MEDEXTEST in-between study subgroups (age, gender and type of disease) is expected to be of no significant difference.
Query!
Assessment method [2]
3370
0
Query!
Timepoint [2]
3370
0
Query!
Secondary outcome [3]
3371
0
The observed sensitivity and specificity of the MEDEXTEST intra-device variability is expected to be of no significant difference.
Query!
Assessment method [3]
3371
0
Query!
Timepoint [3]
3371
0
Query!
Secondary outcome [4]
3372
0
The secondary outcome will be measured and evaluated at the completion of the MEDEXTEST and other investigations (EGD with or without biopsy and Urea Breath Test) on all 200 study participants.
Query!
Assessment method [4]
3372
0
Query!
Timepoint [4]
3372
0
Query!
Eligibility
Key inclusion criteria
200 male and female outpatients with clinical symptoms of active digestive disease will be enrolled into the study. The recruitment process of study participants will assure that the baseline characteristics (age, BMI and gender) will be similar.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
Not stated
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Those patients who are amputees, preganant or suffering form local skin damage in the areas of Medex Test examination.
Query!
Study design
Purpose of the study
Diagnosis
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
All physicians and technicians will be blind to each others examination and MEDEXTEST findings.
Query!
Phase
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
31/07/2006
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
1532
0
Commercial sector/Industry
Query!
Name [1]
1532
0
Medex Screen (AustralAsia) Pty Ltd
Query!
Address [1]
1532
0
Query!
Country [1]
1532
0
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Medex Screen (AustralAsia) Pty Ltd
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
1346
0
None
Query!
Name [1]
1346
0
NONE
Query!
Address [1]
1346
0
Query!
Country [1]
1346
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
2955
0
Sydney West Area Health Service Human Research Ethics Committee - Nepean Campus
Query!
Ethics committee address [1]
2955
0
Query!
Ethics committee country [1]
2955
0
Australia
Query!
Date submitted for ethics approval [1]
2955
0
Query!
Approval date [1]
2955
0
Query!
Ethics approval number [1]
2955
0
06/003
Query!
Summary
Brief summary
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
35598
0
Query!
Address
35598
0
Query!
Country
35598
0
Query!
Phone
35598
0
Query!
Fax
35598
0
Query!
Email
35598
0
Query!
Contact person for public queries
Name
10419
0
Johel Neiron
Query!
Address
10419
0
Medex Screen (AustralAsia) Pty Ltd
Unit 5
20 Twickenham Rd
Burswood WA 6100
Query!
Country
10419
0
Australia
Query!
Phone
10419
0
+61 8 94721184
Query!
Fax
10419
0
+61 8 94703836
Query!
Email
10419
0
[email protected]
Query!
Contact person for scientific queries
Name
1347
0
Associate Professor Martin Weltman
Query!
Address
1347
0
Nepean Hospital
PO Box 63
Penrith NSW 2751
Query!
Country
1347
0
Australia
Query!
Phone
1347
0
+61 2 47343332
Query!
Fax
1347
0
+61 2 47343145
Query!
Email
1347
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF