Evaluation of SureCore Plus Biopsy System
ConditionBPH
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorUro-1 Medical
About this trial
This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient has BPH requiring a prostate biopsy
Able and willing to provide consent
Disqualifiers
Active infection
Subject participating in an other device study of the prostate
Trial design
Design model
Parallel
Treatments tested in this trial
Evaluation of two biopsy systems
DeviceEach subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: SureCore Plus biopsy needleExperimental treatment 1 intervention
Group B: Standard of Care biopsy needleActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Procedure success
\> 3 mm/cc of tissue collected in each biopsy
Time frame
During the procedure2
Quality of biopsy tissue
Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome.
Time frame
During the procedureSecondary outcomes
1
Performance of the study device
Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome.
Time frame
During the procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: