## Protocol Section
### Identification Module
**NCT ID:** NCT06424912

**Brief Title:** 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

#### Organization Study ID Info
**ID:** CIP-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Vivifi Medical
### Status Module
#### Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** RQMplus

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Vivifi Medical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Benign Prostatic Hyperplasia

- Varicocele Grade II

- Varicocele Grade III

**Keywords:**

- BPH

- Varicocele

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Prospective, non-randomized first-in-man study

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Vivifi's Surgical Procedure

**Label:** Treatment Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment Group

**Description:** 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.

**Name:** Vivifi's Surgical Procedure

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** PRIMARY SAFETY ENDPOINT

**Time Frame:** will be assessed up to 12-month post-procedure follow-up.

**Description:** 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.

**Measure:** PRIMARY EFFICACY ENDPOINT

**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

#### Secondary Outcomes

**Description:** 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.

**Measure:** SECODARY EFFICACY ENDPOINT 1

**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

**Description:** Changes in size (volume) of the prostate measured by transrectal ultrasound and cystoscope in mL.

**Measure:** SECODARY EFFICACY ENDPOINT 2

**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

**Description:** Change in peak urinary flow (Qmax) in mL/sec.

**Measure:** SECODARY EFFICACY ENDPOINT 3

**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

**Description:** Change in post-void residual urine volume in mL.

**Measure:** SECODARY EFFICACY ENDPOINT 4

**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

### Eligibility Module

**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

**Maximum Age:** 75 Years

**Minimum Age:** 40 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yideng@rqmplus.com

**Name:** Yiming Deng

**Phone:** 4083966040

**Role:** CONTACT

**Contact 2:**

**Email:** tushar@vivifimedical.com

**Name:** Tushar Sharma

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Panama City

**Country:** Panama

**Facility:** National Hospital

**State:** Punta Pacifica

#### Overall Officials

**Official 1:**

**Affiliation:** Vivifi Medical (Chief Medical Officer)

**Name:** Nathan Starke, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14334

- Name: Prostatic Hyperplasia

- Relevance: HIGH

- As Found: Prostatic Hyperplasia

- ID: M17394

- Name: Varicocele

- Relevance: HIGH

- As Found: Varicocele

- ID: M10016

- Name: Hyperplasia

- Relevance: HIGH

- As Found: Hyperplasia

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011470

- Term: Prostatic Hyperplasia

- ID: D000014646

- Term: Varicocele

- ID: D000006965

- Term: Hyperplasia

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
