Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424912
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-13
Brief Title:
Vivifis Treatment BPH Treatment Via Vasculature Anastomosis
Sponsor:
Vivifi Medical
Organization:
Vivifi Medical
Study Overview
Official Title:
Vivifis Treatment BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study objective is to evaluate the safety and feasibility of the Vivifis Treatment
The Vivifis Treatment presents an innovative approach for addressing benign prostatic hyperplasia BPH as well as clinicalsubclinical varicoceles in men The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifis Treatment a surgical procedure as a therapeutic intervention for patients with BPH
The Vivifis Treatment presents an innovative approach for addressing benign prostatic hyperplasia BPH as well as clinicalsubclinical varicoceles in men The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifis Treatment a surgical procedure as a therapeutic intervention for patients with BPH
Detailed Description:
Current BPH treatments fall into two major categories
1 Surgical removaldestruction 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 Vivifis 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 Vivifis 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
1 Surgical removaldestruction 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 Vivifis 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 Vivifis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None