Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

NCT ID: NCT06424912

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2026-06-30

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.

Conditions

Benign Prostatic Hyperplasia; Varicocele Grade II; Varicocele Grade III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Subjects undergo Vivifi's surgical procedure for treatment of BPH.

Group Type: EXPERIMENTAL

Vivifi's Surgical Procedure

Intervention Type: PROCEDURE

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.

Interventions

Vivifi's Surgical Procedure

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

RQM+

INDUSTRY

Sponsor Role: collaborator

Vivifi Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Starke, MD

Role: STUDY_CHAIR

Vivifi Medical (Chief Medical Officer)

Locations

Hospital Paitilla

Panama City, Provincia de Panamá, Panama

Site Status: RECRUITING

Countries

Panama

Central Contacts

Yunlong Zhang, Master of Science

Role: CONTACT

pzhang@rqmplus.com

669-203-9308

Tushar Sharma, CEO of Vivifi (Study sponsor)

Role: CONTACT

tushar@vivifimedical.com

Facility Contacts

Natalia Vega, Director

Role: primary

nvega@candmresearch.org

(011) 507-6499-9304

Other Identifiers

CIP-001

Identifier Type: -

Identifier Source: org_study_id