Trial Information

Clinical Investigation on a Device for the Diagnosis of Rectal Cancer

Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal
cancer risk. Exclusion criteria consisted of age younger than 18 years, history of
psychiatric illness, and preoperative radiotherapy.

Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe
(TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a
nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency
spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease
of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The
test was performed while the patient stood 120 cm from the receiver. The operator was on the
opposite side of the examined pelvis. No metallic objects were allowed on the patient and no
electronic devices were admitted in the test area. The detector was kept at close contact to
the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis
volume. Based on the investigators previous study, we used the electromagnetic detection
system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the
examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the
anal verge.