"APPROVED" Rector of the Siberian Medical University Academician of the Russian Academy of Medical Sciences Professor                 /signature/         M.A.Medvedev Seal of the Siberian Medical University

PROTOCOL

Medical Tests of Series Specimens
of the Autonomous Electrostimulator of Gastrointestinal Tract
and Mucosa (AES GIT M)

Grounds:

The USSR Minister of Health Protection Order No. 58 dated January 16, 1985 "Permission to apply the autonomous electrostimulator of gastrointestinal tract to medical practice"

    1. During the period since January 1, 1992 till December 31, 1992, the Clinic of Hospital Surgery of the Siberian Medical University performed medical tests of the Autonomous Electrostimulator of Gastrointestinal Tract and Mucosa (AES GIT M), which is developed by the ECOMED Research and Production Association in collaboration with the TECHNOLOGY-2000 Production Cooperative and is produced in small series by the ECOMED Research and Production Association in accordance with Technical Conditions 9444-014-11555014.

    2. Because the AES articles are produced under the monopoly of the enterprises of the ECOMED Research and Production Association and no analogous articles are produced in the USSR, these comparative tests were not prescribed by the Program and Procedure of Tests.

    In order to carry out medical tests, the ECOMED Research and Production Association submitted:

        a) Series specimens of the AES GIT M articles (100 pieces);

        b) Technical documentation including Technical Conditions 9444-014-11555014 (project); the Instruction for medical applications of AES GIT M (approved by the USSR Ministry of Health Protection Commission for New Technologies, Protocol No. 10 dated November 10, 1991), the Program and Procedure of Tests, and the Report on Lipid Metabolism Correction dated March, 18, 1992 to the All-Union Enterological Research Center of the Academy of Medical Sciences.

    3. Brief technical characteristic of AES GIT M:

The Autonomous Electrostimulator is assigned for isolated electric stimulation of stomach, duodenum, duct system of pancreas and extrahepatic ducts, small and large intestines, and rectum as well as for correction of lipid metabolism, treatment of secondary diabetes, and for other purposes specified in the instruction.

    AES GIT M is designed in the form of a small capsule with the length of 22 mm and the diameter of 11 mm and includes two hemispheres, which act as electrodes. The capsule has a microunit inside that acts as a pulse generator and a power source.

    AES GIT M operates in the standby regime and is automatically switched on when placed in the acid medium of stomach or intestines. Meanwhile, it generates electric pulses of special amplitude, duration, and frequency that affect gastric or intestinal mucosa and produce their response in the form of a peristaltic wave, which moves the stimulator to the distal sections. While passing, AES GIT M performs gradual consequent stimulation of all the sections of the gastrointestinal tract.

    Three modifications of AES GIT M are produced in series. Under permanent loading, AES-01 operates for 50 hours, AES-02 operates 300 hours, and AES-03 operates 450 hours.

    The weight of AES GIT M is no more than 5.5 g.

    AES GIT M is produced in the form of a capsule with the length of 22 mm and the diameter of 11 mm packed in its individual package.

    4. The medical tests were carried out in accordance with the program of investigation of the electrostimulation influence on the parietal digestion for healthy persons and patients. The tests involved 74 persons in total. The following groups of examinees were distinguished: healthy persons, patients with gastritis, and patients with gastric and duodenal ulcers. All these three groups of examinees were subjected to investigation of parietal digestion by aspiration of the gastric contents in common sounding and sounding with application of the electrostimulator.

    The main objective of this investigation was to discover the influence of electrostimulation on the composition of the mucus in the gastrointestinal tract and on parietal digestion.

    The composition of the perivisceral and parietal gastric mucus was determined as follows: the gastric aspirates were centrifuged and separated into the apparent perivisceral mucus and juice (supernatant). In turn, the perivisceral mucus was subjected to purification from admixtures, and the concentrations of structural glycoproteins of mucus were determined (proteins, galactose, fucose, and sialic acid), then the overall concentration of monosaccharides per 1 mg of proteins was calculated (degree of glycosilation of glycoprotein molecules), and the partial composition of some monosaccharides was determined. These parameters characterize the processes of mucus biosynthesis. After purification of the apparent or perivisceral mucus, all the extrastructural components of mucus pass into the supernatant, where we determined the concentrations of only some components (nucleic acids, bicarbonates, hydrogen ions, proteolytic enzymes, proteins, and degraded components of structural glycoproteins) that enables us to estimate the intensity of mucus degradation. The same components were determined in the gastric juice. The comparison of distribution of these components in different fractions of perivisceral secretion enables us to estimate the degree of functional interaction between them and the composition of structural glycoproteins.

    The statistical processing was carried out with an IBM AT computer using the SAS and STATGRAPHICS packages.

    5. The reliably different parameters were observed in the groups of patients with the same pathologies either with electrostimulation or without electrostimulation:

	without e/s	with e/s	T	P
** Group of healthy examinees
HC03_OUT	0.00574	0.004287	-4.3193	0.000800
GAL_S	4.4900	2.8347	2.1034	0.044600
NUKL_S	0.07560	0.80607	-5.3974	0.000100
PEPSIN_S	73.543	47.679	2.5461	0.018100
** Group of patients with gastritis
BEL_IN	1.0673	3.0800	-2.7070	0.020600
E_BEL_IN	20.489	8.8409	2.7500	0.015500
NANA_OUT	0.47709	0.73291	-2.2838	0.035700
BEL_OUT	1.8145	Ç.6236	-4.3964	0.000700
AH_OUT	3.5782	5.7982	-3.8507	0.001900
GAL_S	2.1364	4.0664	-2.6748	0.019900
FUC_S	1.6900	3.4291	-2.4313	0.027600
NANA_S	0.16873	0.27354	-2.2941	0.036500
NUKL_S	0.07845	0.88318	-7.2972	0.000100
HÑÎ3	0.00785	0.00215	4.3988	0.000400
ÀÍ	1.9473	5.5527	-4.6276	0.000800
** Group of patients with ulcer
GA_OUT	18.204	13.021	2.4138	0.026200
FUC_OUT	13.281	8.0409	3.5539	0.002400
AH_OUT	3.9136	6.1855	-3.1584	0.005000
BEL_S	1.6290	1.2305	2.4385	0.024800
NUKL_S	0.14127	0.71627	-4.2128	0.001000
PEPSIN_S	81.204	43.720	3.1319	0.005600
HCO3	0.00978	0.00110	8.5728	0.000100
ÀH	3.1500	5.8727	-2.8887	0.009100

    6. There are no remarks to the maintenance documents submitted.

CONCLUSION

    1. The changes, which take place in the mucus composition upon electrostimulation of healthy examinees, are different from the changes, which take place upon electrostimulation of patients with gastritis or gastric or duodenal ulcers.

    2. Upon electrostimulation, healthy examinees did not show any changes in the composition of parietal mucus, whose structure and protective properties are retained. Electrostimulation produces a reliable increase in the concentration of nucleic acids and a decrease in the concentration of pepsin in gastric juice that can be accounted for by the intensified desquamation of epithelium and the accelerated evacuation of gastric contents. An increase in the concentration of bicarbonates in the extrastructural components of mucus upon electrostimulation indicates the strengthened protective function of mucus due to the increased generation of carbon dioxide.

    3. Unlike healthy examinees, patients with gastritis subjected to electrostimulation showed a more apparent and comprehensive effect on parietal digestion. The absolute amount of proteins in the parietal mucus is increased together with the concentration of proteins in the mucus molecules (the degree of glycosilaton of the molecule). We observed a reliable increase in the concentrations of proteins and sialic acid in the extrastructural fraction of mucus and in the concentrations of fucose, galaclose, sialic acid, and nucleic acids in the gastric juice.

    As a positive effect, we should note a significant reduction in pH from 1,9 ± 0,1 to 5,5 ± 0,7 that is rather desirable in treatment of hyperacidity gastritis.

    4. Upon electrostimulation, the patients with gastroduodenal ulcers showed a reduction in acidity of the gastric juice from 3,15 ± 0,66 to 5,87 ± 0,66 (like the patients with gastritis). The concentrations of galactose and fucose are decreased in the extrastructural fractions of mucus; the concentrations of proteins, pepsin, and bicarbonates in the gastric juice are also decreased.

    5. Electrostimulation can be applied to the complex treatment of hyperacidity gastritis and gastroduodenal ulcers.

    6. On the basis of tests performed, the instruction for application of AES GIT M should be corrected in the part of contraindications in ulcerous processes of gastrointestinal tract.

	Head of the Chair of Hospital Surgery of the Siberian Medical University, doctor of medical sciences, Professor		/signature/		G.Ts.Dambaev
	Hospital physician		/signature/		M.M.Soloviov
December 30, 1992

    The tables with the original data are given below. Six groups are distinguished as follows: