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Approvedby the director of Central Dermatology and Venereology Research Instituteof Public Health and Medical Industry Ministry(Russian Federation)academician of Russian Academy of Medical Science,Professor, Dr. Y.K. Scripkin

 

Clinical Trial Protocol of the RTM-01

 

The RTM-01 is a medical radiometer designed by RES, Ltd., a branch of the ARIRE.

Over the period from May to August 1996, in the physiotherapy department of Central Dermatology and Venereology Research Institute of Medical Industry and Public Health Ministry (Russian Federation) the diagnostic abilities of the RTM-01 medical radiometer were explored. Patients having chronic adnexitis were examined.

The operation of the device bases on measuring the intensity of natural electromagnetic radiation from the internal organs of human body at microwave frequencies. The depth of measurement is 3 to 10 cm. The accuracy of a measuring temperature abnormality is ± 0.2 0C

18 women having chronic adnexitis (aged from 19 to 37) were examined and monitored. Also there were 6 healthy volunteers (aged from 20 to 30).

The radiometry examinations were carried out before and after treatment that included the low-intensity laser-therapy and generally indicated drug treatment.

For measuring the temperature of the internal organs the antenna was put on abdominal wall of right and left ovary, over uterine fundus, over right and left edges of uterus, on the left and right lymph. To reduce the external noise all measurements were carried out in shielding tent.

The trial showed that the patients having chronic adnexitis had the increase in temperature of 1...2 0C at the tested points in comparison with the temperature at corresponding points of the healthy volunteers. Also the measured temperature of the inflamed and normal adnexa was compared. The average increase in temperature of the inflamed adnexa in comparison with the normal adnexa was 1.2 0C (p< 0.001). After treatment the temperature fell. And it approached the temperature of the normal adnexa (the confidence coefficient was 0,02 or less). But there had been still 1.30C average increase in temperature in comparison with the temperature of the healthy volunteers.

The received data coincided with ultrasound investigation of uterus and oviducts.

Thus, the clinical trial indicated that the RTM-01 radiometer could be used in cases of chronic adnexitis for diagnostic purposes (for example for primary examinations or check-up in observation room) as well as for the monitoring of treatment.

Signed by

Chief-executor, doctor of medical science, Balura E.V.

Head of physiotherapy department, doctor of medical science,

Volnukhin V.A.

August 26, 1996.

This is a translation. The original is in Russian.

 

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