Diagnosis of Rectal Cancer by Electromagnetic Device
Clinical Investigation on a Device for the Diagnosis of Rectal Cancer
1 other identifier
interventional
442
1 country
1
Brief Summary
The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal \< 50 units (U).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedAugust 24, 2009
August 1, 2009
11 months
August 20, 2009
August 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
6 months
Study Arms (1)
Electromagnetic measurement
OTHERElectromagnetic measurement to detect rectal cancer.
Interventions
RC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, 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. 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 our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
Eligibility Criteria
You may qualify if:
- Gastrointestinal disease or clinical symptoms related to colorectal cancer risk.
You may not qualify if:
- Age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Istituto Nazionale Tumori
Milan, MI, 20133, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 24, 2009
Study Start
January 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 24, 2009
Record last verified: 2009-08