Clinical trial NCT06424912: Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
Official title: Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Varicocele Grade II
Varicocele Grade III
Keywords: BPH
Varicocele
Lead sponsor: Vivifi Medical
Sponsor class: INDUSTRY
Collaborators: name: RQMplus
First posted: 2024-05-22
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized first-in-man study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Current BPH treatments fall into two major categories:

1. Surgical removal/destruction of prostatic tissues:

   1. Transurethral resection of the prostate (TURP)
   2. Holmium laser enucleation of the prostate (HoLEP)
   3. Aquablation - (Procept)
   4. Prostatic artery embolization (PAE)
2. Minimally-invasive Surgical Therapies (MISTs)

   1. Itind (now Olymus)
   2. Urolift (now Teleflex)
   3. Rezum (now Boston Scientific)
   4. TUNA
   5. Zenflow (in trials)
   6. Butterfly Medical (in trials)

The solutions in the first category rely in removing or destroying prostatic tissue. Though effective at reducing urinary symptoms, this damage to the tissue can cause a number of complications. The "non-surgical" solutions fall into the second category. One of the best-studied of these, Urolift, is an implant-based therapy, using internal sutures that are deployed though the urethra that pull the prostatic tissue away from the urethra lumen, repristinating urethral patency. A significant percentage of cases show recurrence of symptoms due to the fact that the prostate continues to grow. Looking at the currently available treatment options, the longer-lasting surgical procedure (group 1). Group 1 procedures, especially TURP, remain "the gold standard" by which all other BPH treatment options are measured.

The Vivifi's Treatment aims to fill the therapeutic gap between the two-category approaches by offering patients a less invasive surgical approach that (1) fixes the root cause of the problem, guaranteeing long lasting effects and (2) does not cause any damage to the prostatic tissue and urethra, thereby preventing the side effects mentioned above. By replumbing a faulty localized vasculature, the Vivifi's technology leverage years of safety data for anastomotic coupling rings enabling it for vascular surgical approaches. These initial clinical studies will prove that this totally novel treatment approach to BPH is safe.

Eligibility criteria: 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

Primary outcomes:
measure: PRIMARY SAFETY ENDPOINT
timeFrame: will be assessed up to 12-month post-procedure follow-up.
measure: PRIMARY EFFICACY ENDPOINT
timeFrame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
Secondary outcomes:
measure: SECODARY EFFICACY ENDPOINT 1
timeFrame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
measure: SECODARY EFFICACY ENDPOINT 2
timeFrame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
measure: SECODARY EFFICACY ENDPOINT 3
timeFrame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
measure: SECODARY EFFICACY ENDPOINT 4
timeFrame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Hospital Paitilla
Study officials:
affiliation: Vivifi Medical (Chief Medical Officer)
name: Nathan Starke, MD
role: STUDY_CHAIR
References: