Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539442
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Versius Paediatrics Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Clinical Study to Assess the Safety and Efficacy of Versius in Urological Procedures in Paediatrics
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is prospective multi-phase single arm multi-centre multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius robotic surgery medical device in Urological Procedures in Paediatric population In alignment with IDEAL Idea Development Exploration Assessment Long-term study Framework this study will consist of 3 main phases to ensure proper procedure development while ensuring patients safety Feasibility and safety will be assessed on an ongoing basis and specifically after completion of the first 3 procedures at a single site SouthamptonLead each conducted one week apart to allow the identification of unanticipated risksadverse events Once deemed safe based on the results of the 3 cases enrolled in Phase I 7 further cases would be completed at the same site Once the procedure is deemed safe according to safety data collected the recruitment will proceed to full trial patient accrual 140 additional cases from the 3 participating study sitesThe study patient population is children and adolescents under the age of 18 which will be provided clinical care and follow-ups per standard of care and hospitals policy
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