Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537947
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
SENTANTE Fully Robotic Peripheral Endovascular Interventions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Center First in Human Study to Evaluate the Feasibility of the SENTANTE Robotic System Application in Peripheral Endovascular Interventions
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ESSENTIAL
Brief Summary:
The objective of the study is to evaluate the feasibility safety and initial efficacy of the clinical and technical performance of the SENTANTE robotic system in the remote delivery and manipulation of commonly used and compatible guidewires and catheter-based devices for use in peripheral endovascular procedures
The study will be a single-center prospective investigation designed to evaluate the safety feasibility and initial efficacy of robotic system for remote endovascular interventions in adults with disease which requires peripheral endovascular treatment with compatible devices Participants meeting the inclusion criteria will undergo endovascular interventions using SENTANTE robotic system Data will be collected through clinical assessments imaging and other studies laboratory tests and feedback from medical personnel and patients
The study will adhere to ethical guidelines obtain informed consent from all participants and be conducted under the oversight of the Clinical Events Committee
The study will be a single-center prospective investigation designed to evaluate the safety feasibility and initial efficacy of robotic system for remote endovascular interventions in adults with disease which requires peripheral endovascular treatment with compatible devices Participants meeting the inclusion criteria will undergo endovascular interventions using SENTANTE robotic system Data will be collected through clinical assessments imaging and other studies laboratory tests and feedback from medical personnel and patients
The study will adhere to ethical guidelines obtain informed consent from all participants and be conducted under the oversight of the Clinical Events Committee
Detailed Description:
None
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