Flexiva Pulse Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-013028
NCT ID: NCT05027971
Sponsor Protocol Number: U0703
About this study
The purpose of this study is to obtain post-market safety and effectiveness data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
For Lithotripsy cohort:
- Subject is undergoing treatment for urinary calculi.
- Subject is willing and able to return for all follow-up visits.
For BPH cohort:
- Subject is ≥ 40 years of age 2.
- Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms.
- IPSS (International Prostate Symptom Score) ≥ 12.
- Qmax (Peak Flow Rate) ≤ 15 mL/s.
- Subject is willing and able to return for all follow-up visits.
Exclusion Criteria:
For Lithotripsy cohort:
- Subject has uncontrolled bleeding disorders and coagulopathy.
- Subject has untreated urinary tract infection (UTI).
- Subject requires simultaneous HoLEP procedure.
For BPH cohort:
- Subject has a diagnosis of bladder cancer.
- Subject has a diagnosis of prostate cancer.
- Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy.
- Subject has acute prostatitis, a prostate abscess, or neurogenic bladder.
- Subject has urethral stricture disorder.
- Subject has uncontrolled bleeding disorders and coagulopathy.
- Subject has untreated urinary tract infection (UTI).
- Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi).
Eligibility last updated 12/16/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mitchell Humphreys, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available