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NCT02307552 · OUTCOME

Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer

Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer · Source last updated 2017-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
one year

What was measured

The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis

Analysis population: Data were not collected because the study was discontinued due to lack of feasibility and negative results.

Groups in this outcome

All Patients

All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy. UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Patients0

Reported measurements

Source class 1
Values in Not reported · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis
groups
  1. description
    All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy. UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.
    id
    OG000
    title
    All Patients
population Description
Data were not collected because the study was discontinued due to lack of feasibility and negative results.
reporting Status
POSTED
time Frame
one year
title
Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer
type
PRIMARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice