Clinical trial NCT02828839: Prostate Biopsy Access Needle & Needle Guide Feasibility Study
Official title: Prostate Biopsy Access Needle & Needle Guide Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Transperineal
Transrectal
Needle Guide
Biopsy
Lead sponsor: Perineologic
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 230
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Assessment of the handling characteristics of the access needle and needle guide.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cumberland
country: United States
facility: Corbin Clinical Resources
state: Maryland
Study officials:
affiliation: Perineologic
name: Matthew J Allaway, DO
role: STUDY_DIRECTOR
References:
citation: Rodriguez LV, Terris MK. Risks and complications of transrectal ultrasound guided prostate needle biopsy: a prospective study and review of the literature. J Urol. 1998 Dec;160(6 Pt 1):2115-20. doi: 10.1097/00005392-199812010-00045.
citation: Emiliozzi P, Corsetti A, Tassi B, Federico G, Martini M, Pansadoro V. Best approach for prostate cancer detection: a prospective study on transperineal versus transrectal six-core prostate biopsy. Urology. 2003 May;61(5):961-6. doi: 10.1016/s0090-4295(02)02551-7.