ANZCTR - Registration

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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

Condition category

Condition code

Oral and Gastrointestinal

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

Primary outcome [3]

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]

Secondary outcome [1]

The secondary objective is to evaluate the technical intra-device variability between Medex Test devices.

Timepoint [1]

Secondary outcome [2]

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]

Secondary outcome [3]

The observed sensitivity and specificity of the MEDEXTEST intra-device variability is expected to be of no significant difference.

Timepoint [3]

Secondary outcome [4]

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]

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?

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]

Commercial sector/Industry

Name [1]

Medex Screen (AustralAsia) Pty Ltd

Address [1]

Country [1]

Primary sponsor type

Commercial sector/Industry

Name

Medex Screen (AustralAsia) Pty Ltd

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

NONE

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney West Area Health Service Human Research Ethics Committee - Nepean Campus

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Johel Neiron

Address

Medex Screen (AustralAsia) Pty Ltd
Unit 5
20 Twickenham Rd
Burswood WA 6100

Country

Australia

Phone

+61 8 94721184

Fax

+61 8 94703836

johel@medexaus.com

Contact person for scientific queries

Name

Associate Professor Martin Weltman

Address

Nepean Hospital
PO Box 63
Penrith NSW 2751

Country

Australia

Phone

+61 2 47343332

Fax

+61 2 47343145

weltmam@wahs.nsw.gov.au

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.

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