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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
Scientific title
Evaluation of the Medex Test for the Detection of Gastrointestinal Disorders
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Disorders 1311 0
Condition category
Condition code
Oral and Gastrointestinal 1398 1398 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1230 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

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.
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.
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.
Timepoint [2] 1912 0
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.
Timepoint [3] 1913 0
Secondary outcome [1] 3369 0
The secondary objective is to evaluate the technical intra-device variability between Medex Test devices.
Timepoint [1] 3369 0
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.
Timepoint [2] 3370 0
Secondary outcome [3] 3371 0
The observed sensitivity and specificity of the MEDEXTEST intra-device variability is expected to be of no significant difference.
Timepoint [3] 3371 0
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.
Timepoint [4] 3372 0

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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those patients who are amputees, preganant or suffering form local skin damage in the areas of Medex Test examination.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All physicians and technicians will be blind to each others examination and MEDEXTEST findings.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1532 0
Commercial sector/Industry
Name [1] 1532 0
Medex Screen (AustralAsia) Pty Ltd
Country [1] 1532 0
Primary sponsor type
Commercial sector/Industry
Name
Medex Screen (AustralAsia) Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 1346 0
None
Name [1] 1346 0
NONE
Address [1] 1346 0
Country [1] 1346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2955 0
Sydney West Area Health Service Human Research Ethics Committee - Nepean Campus
Ethics committee address [1] 2955 0
Ethics committee country [1] 2955 0
Australia
Date submitted for ethics approval [1] 2955 0
Approval date [1] 2955 0
Ethics approval number [1] 2955 0
06/003

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35598 0
Address 35598 0
Country 35598 0
Phone 35598 0
Fax 35598 0
Email 35598 0
Contact person for public queries
Name 10419 0
Johel Neiron
Address 10419 0
Medex Screen (AustralAsia) Pty Ltd
Unit 5
20 Twickenham Rd
Burswood WA 6100
Country 10419 0
Australia
Phone 10419 0
+61 8 94721184
Fax 10419 0
+61 8 94703836
Email 10419 0
[email protected]
Contact person for scientific queries
Name 1347 0
Associate Professor Martin Weltman
Address 1347 0
Nepean Hospital
PO Box 63
Penrith NSW 2751
Country 1347 0
Australia
Phone 1347 0
+61 2 47343332
Fax 1347 0
+61 2 47343145
Email 1347 0
[email protected]

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

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