Prostate Biopsy Access Needle & Needle Guide Feasibility Study
Completed · Not applicable
Conditions studied: Prostate Cancer
In brief
The objective of the study is to assess the design features of a modified stainless steel access needle (single use disposable) in a clinical setting and a disposable, single use, custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. The disposable stainless steel access needle may be used with or without the disposable needle guide, but will always be used with ultrasound image guidance and a biopsy gun. The primary purpose of the single-use disposable access needle is to guide the use of a biopsy gun to obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of the perineum. The primary purpose of the disposable needle guide is to stabilize the needle biopsy and better approximate the most direct path to the prostate.
Key facts
- Study ID
- NCT02828839
- Run by
- Perineologic
- People needed
- 230
- Starts
- 2015-11-01
- Expected to finish
- 2022-01-31
- Last updated by the study team
- 2022-02-21
Who can join
Age: 18 and older, up to 80. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Males requiring a needle-biopsy of the prostate with ultrasound assistance via a trans-rectal ultrasound probe
- Otherwise healthy patient with no serious acute or chronic illness
You may not qualify if…
- Patients with a partial or complete prostectomy
- Patients with active infection of the prostate, perineum, rectum, bowel, or peritoneum
- Patients with serious acute or chronic illness
- Cannot read and comprehend simple instructions in English
- Poorly controlled psychiatric disease
- Females
Where it is running
- Corbin Clinical Resources — Cumberland, Maryland, United States
Full record on ClinicalTrials.gov
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