Prostate Biopsy Access Needle & Needle Guide Feasibility Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/17/2018 |
| Start Date: | November 2015 |
| End Date: | May 30, 2019 |
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.
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.
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 with 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. For some
subjects, the study will assess the fit and functionality of the stainless steel access
needle when used in conjunction with the disposable needle guide as well as multiple handling
aspects of the access needle and disposable needle guide when utilized in a prostate biopsy
procedure. The study will also assess the ability of trans-rectal ultrasound to appropriately
image the stainless steel access needle and biopsy gun needle at, near, and within the
prostate tissue.
access needle (single use disposable) in a clinical setting with 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. For some
subjects, the study will assess the fit and functionality of the stainless steel access
needle when used in conjunction with the disposable needle guide as well as multiple handling
aspects of the access needle and disposable needle guide when utilized in a prostate biopsy
procedure. The study will also assess the ability of trans-rectal ultrasound to appropriately
image the stainless steel access needle and biopsy gun needle at, near, and within the
prostate tissue.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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