| Gustave Roussy Institute (Villejuif, France) 2002 |
| Summary |
| A group of 39 patients who had undergone chemotherapy treatment were seen at Gustave Roussy Institute (IGR) in France, with the aim of investigating the specificity of a graph called the Electrosomatogram (ESG) generated by the EIS device. After statistical study with the STATISTICA program, version 6.0, it appeared that the ESG graph presented a level of sensitivity of 100% (IC calculated at 95%) compared to the reference base and a level of specificity of 89% (IC calculated at 95%). |
The focus of this pre-study was three-fold
|
| Key words: Anticancer treatments- EIS device. ESG Graph - sensitivity of 100% (IC calculated to 95%) and a specificity of 89% (IC calculated to 95%) - determination of the number of patients for clinical investigations |
| St Louis Hospital (Paris France) 2003 |
| Summary |
| A group of 37 male patients with erection disorders (ED) were screened at the Hopital St. Louis (France) under the Andrology Department (Headed by PR G Tritto), in order to test the specificity of a graph called the Electrosomatogram (ESG) generated by a device called the EIS. After statistical study of the base (STATISTICA version 6.0), it appeared that the ESG graph had a sensitivity of 95% (IC calculated to 95%) compared to the reference index provided by the originator of the system, with a specificity of 78% (IC calculated to 95%). The focus of this pre-study is two-fold: |
|
| Calculating the number of patients necessary for such further clinical investigations. |
| Key words: Andrology- EIS device. ESG Graph - sensitivity of 95% (IC calculated to 95%) and a specificity of 78% (IC calculated to 95%) - determination of the number of patients for clinical investigations |
| Botkin Hospital (Moscow,Russia) 2004 |
| Summary |
| The clinical tests undertaken at Botkin Hospital with the aid of the EIS system on 589 patients comprising a panel of 20 groups (1 group of healthy subjects and 19 groups of patients presenting conventionally diagnosed pathologies) allowed the system to acquire new algorithms for inverse problems. |
| The EIS examination was validated as a marker for certain pathologies such as viral hepatitis, hypertension, chronic bronchitis and asthma, cerebral circulatory problems and neurological illnesses plus lower limb circulatory problems, spasmodic colitis and arrhythmia. However, due to a lack of sensitivity it could not be validated in the case of other pathologies other than being a definite marker. |
| The results of these clinical tests combined with direct methods (verification of recorded volumes) led to definition of the localization of organs at the level of modelization which the EIS system is based upon. The only subtle point that remains is the distinction of the different organs of the digestive system. |
| Key words: Algorithms of inverse problems, marker of certain pathologies, modelization |
| SCIENTIFIC MEDICAL CENTER OF REHABILITATION MARFINO (Моscow, Russia) 2004 |
| Justification |
| Following the clinical investigation carried out at the Botkin Hospital from November 2003 to September 2004, with the aim of validating the use of The EIS System as a marker for certain pathologies, it would be interesting to show the realization of this clinical investigation and the validity of its claims: |
| Claim 1: Statistical risks analysis Claim 2: Estimation of the values of the ionogramme Claim 3: Calculation of the percentage of the body fat mass |
| Principal Objective |
The results of The EIS examination were compared with the results from various conventional examinations as well as a predicate device to indicate the statistical percentage of correlation and the confidence interval. |
|
| Hypotheses: |
| The EIS can validate claim 1 And /or The EIS can validate claim 2 And /or EIS can validate claim 3 EIS cannot validate claim 1, 2, and 3 |
| Results |
| Claim 1 of The EIS system : It appears that in 33 patients of group 1, the program indicates the main risk of the patient to 75% accuracy. The criteria outlined for the validation of claim 1 was fixed at 80% with a confidence interval at 95%. Thus claim 1 was not validated and must be the subject of further clinical investigations presenting a more significant number of patients , or to modify the validating criteria.Therefore claim 1is rejected. |
| Claim 2 of The EIS system- It appears that in 33 patients of group 1, the statistical program (STATISTICA version 7.0) having analyzed the correlation between the scale 30/-30 of The EIS software and the laboratory tests confirmed a correlation of 89% with a confidence interval of 95% Therefore claim 2 is validated. |
| Claim 3 of The EIS system: It appears clearly that on the 58 patients of group 2, the EIS software gives results in conformity (standard deviations < to 5% with a confidence interval at 95%) to the AVITA BF1 device . Therefore claim 3 is validated. |
| Botkin Hospital (Moscow,Russia) Final Report of September 15, 2006 |
| Summary |
| Clinical investigations were performed at the S.P. Botkin Hospital from May 20, 2006 to September 1, 2006 in order to evaluate various assumptions made by The EIS System, namely, its aid in medical diagnosis for targeted complementary examinations and for therapeutic follow-up. Following approval by the Ethic Committee and in line with the Declaration of Helsinki, the tests were performed without any accident or side effects, according to the proposed plan of the clinical trial (PIC TC 02). |
| 215 patients were enrolled from the hospital. These patients presented infections diagnosed by complementary and conventional means (thyroid hypo function, hypertension, arteriosclerosis and depression) and were under no current treatment. The EIS System’s program of analysis proposed a functional risk according to a scale from I to IV and complementary follow up examinations. The results took into account the risk I and II plus the conventional exams recommended by The EIS System, in order to evaluate the system as an aid to medical diagnosis. |
| The treatment protocols corresponding to the illnesses were monitored with The EIS System and other conventional methods. Evaluation with the respective systems began following patient registration, with a follow-up undertaken every 15 days. |
| In view of the results obtained at the level of risk analysis by the EIS, interest was found as an aid to medical diagnosis and prescription of targeted supplementary examinations. In effect, the system indicates the supplementary exams for risks I and II and from this point of view the results are remarkable. . Assumptions of the system are therefore well substantiated on the issue of these clinical trials. |
| Key words: EIS – Targeted complementary exams – Therapeutic follow-up |
| Current Protocols and Studies in Progress |
| McLean Hospital Chicago: |
| IRB FDA approval: Harvard Medical School |
| New possibility of diagnosing unipolar and bipolar depression |
| 1. Overview |
| This IDE application proposes to examine a novel bioelectric impedance diagnostic device, The EIS System. The purpose of this investigation is to examine whether The EIS System can distinguish patients with mood disorders from non-ill controlled subjects, and whether this technique can differentiate the patients with unipolar depression from those with bipolar disorders. |
| Dr Caudal Frederic (France): specificity and sensitivity of hyperactivity of children and The EIS system Results in bio statistic. Final results available June 2007 |
| Centro de investigación:Universidad Pontificia Bolivariana (Colombia) : Cardiology and The EIS System |