Prostate Biopsy Access Needle & Needle Guide Feasibility Study

Prostate Cancer Clinical Trial

— STABLE  

Official title:

Prostate Biopsy Access Needle & Needle Guide Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828839
• Other study ID #: P-101
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: Perineologic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Access needle
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.

Locations

Country	Name	City	State
United States	Corbin Clinical Resources	Cumberland	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Perineologic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Rodríguez 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the handling characteristics of the access needle and needle guide.	Assessment of the handling characteristics of the single use, disposable stainless steel access needle and the single use, disposable polymeric needle guide will be completed by the user completing a questionnaire rating various performance characteristics of the access needle and the needle guide at the completion of each prostate biopsy. Using a scale from 1 to 5, with 1 being poor and 5 being excellent, each characteristic of the access needle and the needle will be rated. The results will be summarized across all characteristics and reported as percentages of each rating scale indicator, 1 through 5.	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.

External Links

•   Perineologic approach to prostate biopsies