Prostate Biopsy Access Needle & Needle Guide Feasibility Study

Prostate Biopsy Access Needle & Needle Guide Feasibility Study

Sponsors

Lead sponsor: Perineologic

Source Perineologic
Brief Summary

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.

Detailed 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.

Overall Status Active, not recruiting
Start Date November 2015
Completion Date May 30, 2020
Primary Completion Date December 31, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Assessment of the handling characteristics of the access needle and needle guide. The time point at which this will be measured is at the end of the prostate biopsy procedure up to 30 days through study completion.
Enrollment 500
Condition
Intervention

Intervention type: Procedure

Intervention name: Access needle

Description: 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.

Arm group label: Treatment Arm

Eligibility

Criteria:

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

Gender: Male

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Matthew J Allaway, DO Study Director Perineologic
Location
facility
Corbin Clinical Resources
Location Countries

United States

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Treatment Arm

Arm group type: Experimental

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.

Acronym STABLE
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov