Benign Prostatic Hyperplasia Clinical Trial
Official title:
Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein
Verified date | May 2024 |
Source | Vivifi Medical |
Contact | Yiming Deng |
Phone | 4083966040 |
yideng[@]rqmplus.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study objective is to evaluate the safety and feasibility of the Vivifi's Treatment. The Vivifi's Treatment presents an innovative approach for addressing benign prostatic hyperplasia (BPH) as well as clinical/subclinical varicoceles in men. The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifi's Treatment (a surgical procedure) as a therapeutic intervention for patients with BPH.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2026 |
Est. primary completion date | January 30, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Male 40-75 years of age 2. Diagnosed with Benign prostatic hyperplasia (BPH) 3. Prostate volume: = 30 = 120 cc measured by transrectal ultrasound 4. Signed the study informed consent form (ICF) 5. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12 6. Presence of clinical varicocele (preferably grade II or III - Dubin & Amelar. Exclusion Criteria: 1. Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy 2. Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.) 3. Prostate with large intravesical median lobe 4. Patients with sub-clinical varicocele 5. Post-void residual volume (PVR) > 110ml 6. IPSS (International Prostate Symptoms Score) >24 7. Patients with clinical history of chronic prostatitis. 8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days). 9. Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury 10. Patients that can not be under general anesthesia 11. Patients on blood thinners, or with coagulation related issues, TTP 12. Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc 13. History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study. 14. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements 15. Subject currently participating in other investigational studies unless approved by the Sponsor in writing |
Country | Name | City | State |
---|---|---|---|
Panama | National Hospital | Panama City | Punta Pacifica |
Lead Sponsor | Collaborator |
---|---|
Vivifi Medical | RQMplus |
Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PRIMARY SAFETY ENDPOINT | Assess the safety of the Vivifi's Treatment through the rate & type of the procedure related complications, such as bleeding, infection or other tissue damage. | will be assessed up to 12-month post-procedure follow-up. | |
Primary | PRIMARY EFFICACY ENDPOINT | Assess the changes in International Prostate Symptoms Score (IPSS) from baseline to post-procedure. The score range of the questionnaire is 0 to 35. A higher score indicates worse symptomatic. | to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups. | |
Secondary | SECODARY EFFICACY ENDPOINT 1 | Changes in International Index of Erectile Function (IIEF) questionnaire scores. The questionnaire has 15 questions. Each question is scored from 0-5. A higher score indicates improved erectile function. | to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups. | |
Secondary | SECODARY EFFICACY ENDPOINT 2 | Changes in size (volume) of the prostate measured by transrectal ultrasound and cystoscope in mL. | to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups. | |
Secondary | SECODARY EFFICACY ENDPOINT 3 | Change in peak urinary flow (Qmax) in mL/sec. | to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups. | |
Secondary | SECODARY EFFICACY ENDPOINT 4 | Change in post-void residual urine volume in mL. | to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups. |
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