Benign Prostatic HyperplasiaNCT06424912
Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
A study testing Vivifi's Surgical Procedure in people with Benign Prostatic Hyperplasia and Varicocele Grade II, run by Vivifi Medical at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Varicocele Grade II, Varicocele Grade III
- What is being tested?
- Vivifi's Surgical Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePanama
- Study dates
- 13 Nov 2024to 30 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male 40-75 years of age
- Diagnosed with Benign prostatic hyperplasia (BPH)
- Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
- Signed the study informed consent form (ICF)
- Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
- Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar.
Who cannot join
- Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
- Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
- Prostate with large intravesical median lobe
- Patients with sub-clinical varicocele
- Post-void residual volume (PVR) > 110ml
- IPSS (International Prostate Symptoms Score) >24
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- Patients with clinical history of chronic prostatitis.
- Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).
- Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
- Patients that can not be under general anesthesia
- Patients on blood thinners, or with coagulation related issues, TTP
- Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc
- 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.
- Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements
- Subject currently participating in other investigational studies unless approved by the Sponsor in writing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tushar Sharma, CEO of Vivifi (Study sponsor) contact
Panama1 site, 1 recruiting
- Recruiting
Hospital Paitilla
Panama City, Provincia de Panamá
Natalia Vega, Director, (011) 507-6499-9304, nvega@candmresearch.org
About this study
Official title: Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein
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.
Read the detailed description
Current BPH treatments fall into two major categories:
- Surgical removal/destruction of prostatic tissues:
- Transurethral resection of the prostate (TURP)
- Holmium laser enucleation of the prostate (HoLEP)
- Aquablation - (Procept)
- Prostatic artery embolization (PAE)
- Minimally-invasive Surgical Therapies (MISTs)
- Itind (now Olymus)
- Urolift (now Teleflex)
- Rezum (now Boston Scientific)
- TUNA
- Zenflow (in trials)
- 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.
- Being tested
- Vivifi's Surgical Procedure
- Keywords
- BPH, Varicocele
- Medical subject headings
- Prostatic Hyperplasia, Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivifi's Surgical ProcedureProcedure or surgery
Subjects undergo Vivifi's surgical procedure for treatment of BPH. The study procedure will be performed in the operating room, under general anesthesia.
Subject will undergo a bilateral anastomosis of the internal spermatic vein to the inferior epigastric vein and ligation of the deferential vein via bilateral inguinal/subinguinal incision.
The investigators can use of a coupler with appropriate ring size (to be measured intra-operatively based on vessel size) to perform the vascular anastomosis and standard sutures for ligation. The coupler is an FDA approved commercial device. Alternatively, the anastomosis can also be performed using sutures. Incision closure will proceed per institution standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects undergo Vivifi's surgical procedure for treatment of BPH. Receives: Procedure: Vivifi's Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: will be assessed up to 12-month post-procedure follow-up.
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.
Measured: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
Secondary outcomes (4)
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.
Measured: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
SECODARY EFFICACY ENDPOINT 2
Changes in size (volume) of the prostate measured by transrectal ultrasound and cystoscope in mL.
Measured: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
SECODARY EFFICACY ENDPOINT 3
Change in peak urinary flow (Qmax) in mL/sec.
Measured: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
SECODARY EFFICACY ENDPOINT 4
Change in post-void residual urine volume in mL.
Measured: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start13 Nov 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized first-in-man study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivifi Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Responsible party
- Sponsor
- Investigators
- Nathan Starke, MD, Study chair, Vivifi Medical (Chief Medical Officer)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424912
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Apr 2025
- First submitted
- 13 May 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No