Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT06661902
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* 18 years old or older
* Patients with prostates
* Those with and without a prior diagnosis of prostate cancer
* Recommended to undergo a prostate biopsy in the urology clinic. Only patients that have been scheduled for a biopsy (for clinical purposes) will be enrolled. May include all of the following types of prostate biopsies:
* Transperineal or transrectal
* Systematic or targeted/fusion biopsy
* 12 core biopsy or \> 12cores
* Biopsy naïve or prior biopsy
Exclusion Criteria:
* Anorectal pathology precluding placement of a transrectal ultrasound
* Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
* Concomitant chronic pain condition
* Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)
* Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)
* Prostate biopsy completed in the operating room
* Patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention
* Patients taking anxiolytics in the 6-hours prior to the biopsy
* Those with a known hypersensitivity, allergic reaction, or contraindication to using sodium bicarbonate. This includes patients who are receiving diuretics known to produce a hypochloremic alkalosis
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06661902
Study Brief:
Protocol Section:
NCT06661902