Prostate Biopsy Access Needle & Needle Guide Feasibility Study (STABLE)

Perineologic

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Access needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02828839

P-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 230 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Subjects will receive standard of care prostate biopsies through the use of a trans-rectal ultrasound probe for needle placement and guidance. The intervention for all patients receiving a prostate biopsy will include the use of an investigational single use, disposable stainless steel access needle and a single use, disposable polymeric needle guide.

Treatment:

Procedure: Access needle