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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03428087
Other study ID # 151/2016
Secondary ID
Status Recruiting
Phase N/A
First received February 3, 2018
Last updated February 15, 2018
Start date July 1, 2017
Est. completion date June 30, 2018

Study information

Verified date February 2018
Source University of Pisa
Contact Tommaso Di Vico, Resident
Phone 3393642655
Email urologiapisa@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2018
Est. primary completion date February 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years and older
Eligibility Inclusion Criteria:

1. age> 45 years

2. up of total PSA values beyond the normal range (> 4 ng / ml)

3. presence or absence of suspicious prostate nodule

Exclusion Criteria:

1. previous history of cancer

2. BMI>30

3. patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy AOUP Ospedale cisanello Pisa Toscana

Sponsors (1)

Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impedance-based analysis based on phase-sensitive sensors during rectal examination
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