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CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies

NCT ID: NCT03609528

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2019-10-02

Brief Summary

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The CamPROBE study investigates the rate of infective complications using the Cambridge Prostate Biopsy Device method of local anaesthetic transperineal prostate biopsies.

Detailed Description

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The current method for diagnosing prostate cancer requires a biopsy needle to pass through the bowel wall to reach the prostate. Bacteria in the bowel inevitably enter the urinary system and blood stream. A significant number of men develop infections despite preventative antibiotics (1 in 10 develop fevers/shivers and 1-2 in 100 get a life-threatening infection). It is crucial we find a safer biopsy method for suspected prostate cancer as over 1 million rectal biopsies occur each year.

A safer alternative device was developed, performed under local anaesthetic using the transperineal route: CamPROBE (Cambridge Prostate Biopsy Device). CamPROBE biopsies are taken through the perineum (the area under the testicles), so there is no infection risk, and it's just as good at diagnosing prostate cancer. This investigation progresses from a prototype to a disposable, single use device that any UK hospital can use. The study will assess CamPROBE's ability to reduce infections from prostate biopsies and its usability as an alternative to the current standard biopsies.

Men recommended to undergo a prostate biopsy will be eligible for this multi-centre study. For each patient, the study will take approximately 30 days, consisting of: recruitment, 1 day for the procedure (replaces the standard biopsy pathway) and questionnaires on day 1, 7 and 30. This timeframe will not introduce delays in the patients' normal standard care pathway. Patients will have a transperineal biopsy with CamPROBE instead of the current transrectal method. Biopsy samples will be treated the same as standard procedure. Patients' acceptability of the procedure and complications will be measured using patient self-reported questionnaires.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CamPROBE biopsy method

To be completed

Group Type EXPERIMENTAL

CamPROBE

Intervention Type DEVICE

To be completed

Interventions

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CamPROBE

To be completed

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

To be included in the clinical investigation the participant must:

* Have given written informed consent to participate
* Be aged 18 years and over
* Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic or surveillance purposes
* Be willing and able to comply with scheduled visits and completion of study questionnaires

Exclusion Criteria

The presence of any of the following will preclude participant inclusion:

* Contraindication to a prostate biopsy
* Previous perineal or anal surgery
* Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Cambridge

OTHER

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Vincent Gnanapragasam

Mr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CamPROBE

Identifier Type: -

Identifier Source: org_study_id