Tissue resonance interaction accurately detects colon lesions: A double-blind pilot study

Table 1 Results of the preliminary study to establish criteria for the outcomes assessed in the blinded trial

Spectral line	Normalmucosa	Hyperplasticpolyps	Low-grade1	High-grade2	Adeno
			adenoma	adenoma	carcinomas
	(n= 47)	(n= 29)	(n= 16)	(n= 4)	(n= 10)
465 MHz	0	0	25-30	30-35	60-70
930 MHz	0	> 40	> 40	> 40	35-45
1395 MHz	0	0	0-10	65-70	35-45

¹Low-grade dysplasia;

²High-grade dysplasia. Threshold values are represented in decibel by the hand-held computer (PSA2701T-2.7 GHz RF Spectrum Analyzer Thurlby Thandar Instruments, Ltd, Huntingdon, United Kingdom), spectrum analyzer, for each of the three spectral lines for normal and specific biological anomaly of colonic mucosa.

Table 2 Sensitivity, specificity, positive and negative predictive value of the TRIMprob analysis compared to the gold standard (colonoscopy and histology) in detecting biological anomalies of colonic mucosa for the whole cohort, and for the non-inflammatory bowel disease cohort

Histology	Colonoscopy(No. of positive cases/total No. of cases)	TRIMProb(No. of TP, FP, FN, TN)				Sensitivity, % (95%CI)	Specificity, % (95%CI)	Positive predictive value, % (95%CI)	Negative predictive value, % (95%CI)
All cases	156/305	154	12	2	137	98.7	91.9	92.8	98.6
(IBD + Non IBD)						(95.4-99.6)	(86.4-95.3)	(87.8-95.8)	(94.9-99.6)
Non IBD cases	149/281	147	5	2	127	98.7	96.2	96.7	98.4
						(95.2-99.6)	(91.4-98.4)	(92.5-98.6)	(94.5-99.6)
Hyperplastic1	73/281	71	4	2	204	97.3	98.1	94.7	99
						(90.5-99.2)	(95.2-99.2)	(87.0-97.9)	(96.5-99.7)
Adenomas2	47/281	40	4	7	230	85.1	98.3	90.9	97
						(72.3-92.6)	(95.7-99.3)	(78.8-96.4)	(94.0-98.6)
Advanced adenomas3	17/281	14	1	3	263	82.4	99.6	93.3	98.9
						(58.9-93.8)	(97.9-99.9)	(70.2-98.8)	(96.7-99.6)
Cancer	12/281	12	0	0	269	100	100	100	100
						(75.7-100.0)	(98.5-100.0)	(75.7-100.0)	(98.6-100.0)

¹Hyperplastic polyps of every size;

²Every size adenomas with tubular or villus morphology and low grade dysplasia;

³Every size adenomas with tubular or villus morphology and high grade dysplasia. TP: True positives; FP: False positive; TN: True negative; FN: False negative; IBD: Inflammatory bowel disease.

Table 3 Two hundred eighty-one non-inflammatory bowel disease subjects

281 non-IBD patients	Normal	Hyperplasia	LGD	HGD	Cancer	Total
Colonoscopy
Normal	127	2	0	0	0	129
Hyperplasia	0	73	5	2	0	80
LGD	4	0	40	1	0	45
TRIM
HGD	1	0	0	14	0	15
Cancer	0	0	0	0	12	12
Total	132	75	45	17	12	281

LGD: Low grade dysplasia; HGD: High grade dysplasia; TRIM: Tissue Resonance Interaction Method; IBD: Inflammatory bowel disease.