Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526858
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Early Feasibility Study of HyperQureTM RDN System Laparoscopic Renal Denervation Therapy in Patients With Resistant Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Single Arm Open-label Early Feasibility Study to Evaluate Initial Safety and Device Design Concept of HyperQureTM RDN System Laparoscopic Renal Denervation Therapy in Patients With Resistant Hypertension on Three3 or More Antihypertensive Medications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HQ-HTN-G01 is a prospective multicenter single arm open label early feasibility study to evaluate initial safety and device design concept of HyperQureTM RDN System laparoscopic renal denervation therapy in patients with resistant hypertension on three3 or more antihypertensive medications
Detailed Description:
Study purpose The purpose of this single arm interventional study is to evaluate initial safety and device design concept of HyperQureTM laparoscopicextravascular renal denervation therapy in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic The results of this study will be used to 1 prove the concept of complete ablation by Extravascular RDN and 2 develop a solid reference for a pivotal study
Background and Hypothesis The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters 1incomplete renal denervation 2 risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access and 3 access limitations due to vascular anatomy and vessel size
The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopicextravascular approach Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch andor accessory vessels it is expected that it will be possible to achieve more complete renal denervation reduce the risk of endothelial damage and resolve structural access limitations
Study plan Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascularlaparoscopic RDN under general anesthesia and will have 36month follow up with various BP evaluations24hABP Office BP and Home BP and CTADUS imaging scan evaluations
Background and Hypothesis The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters 1incomplete renal denervation 2 risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access and 3 access limitations due to vascular anatomy and vessel size
The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopicextravascular approach Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch andor accessory vessels it is expected that it will be possible to achieve more complete renal denervation reduce the risk of endothelial damage and resolve structural access limitations
Study plan Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascularlaparoscopic RDN under general anesthesia and will have 36month follow up with various BP evaluations24hABP Office BP and Home BP and CTADUS imaging scan evaluations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None