Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-75
SponsorVivifi Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Vivifi's Surgical Procedure
Procedure/SurgerySubjects 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
will be assessed up to 12-month post-procedure follow-up.2
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.
Time frame
to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.Secondary outcomes
1
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.
Time frame
to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.2
SECODARY EFFICACY ENDPOINT 2
Changes in size (volume) of the prostate measured by transrectal ultrasound and cystoscope in mL.
Time frame
to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.3
SECODARY EFFICACY ENDPOINT 3
Change in peak urinary flow (Qmax) in mL/sec.
Time frame
to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.4
SECODARY EFFICACY ENDPOINT 4
Change in post-void residual urine volume in mL.
Time frame
to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vivifi Medical
Lead sponsor
RQM+
Collaborator
Source ClinicalTrials.gov