Prostate Biopsy Access Needle & Needle Guide Feasibility Study
STABLE
1 other identifier
interventional
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Nov 2015
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFebruary 21, 2022
February 1, 2022
6.3 years
June 30, 2016
February 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Treatment Arm
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Perineologiclead
Study Sites (1)
Corbin Clinical Resources
Cumberland, Maryland, 21502, United States
Related Publications (2)
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.
PMID: 9817335BACKGROUNDEmiliozzi 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.
PMID: 12736016BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Matthew J Allaway, DO
Perineologic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 12, 2016
Study Start
November 1, 2015
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
February 21, 2022
Record last verified: 2022-02