Prostate Cancer Clinical Trial
— CamPROBEOfficial title:
CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies
Verified date | December 2019 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The CamPROBE study investigates the rate of infective complications using the Cambridge Prostate Biopsy Device method of local anaesthetic transperineal prostate biopsies.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2, 2019 |
Est. primary completion date | October 2, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital | Cambridge |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | University of Cambridge |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinician Perception | Clinician perception of the device and the performance of the CamPROBE assessed using Clinical Performance Assessment questionnaire | 1 day | |
Primary | Incidence of Infection | Changes in incidence of infection as measured using patient self-reported Follow-Up Questionnaires and telephone assessments. | 30 days post biopsy | |
Secondary | Patient reported pain score | Patient reported pain scores as measured using patient self-reported questionnaires. | 30 days post biopsy | |
Secondary | Biological functions post biopsy | Patient biological functions as measured using patient self-reported questionnaires | 30 days post biopsy | |
Secondary | Patient willingness to have a repeat biopsy | Patients' willingness to have a repeat biopsy as measured using patient self-reported questionnaires | 30 days post biopsy |
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