Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387485
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-18
Brief Title:
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Sponsor:
Ricoh USA Inc
Organization:
Ricoh USA Inc
Study Overview
Official Title:
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This prospective multi-center randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites Subjects will be randomized in a 11 ratio into either the experimental arm utilizing 3D printed models and imaging or the active comparator arm using only imaging
Primary endpoint Operative time of surgical procedure
Secondary endpoints Reduction of blood loss proportion of postoperative adverse events and negative tumor margins
Exploratory endpoints Surgical planning ease changes in surgical plan and surgeon satisfaction
Primary endpoint Operative time of surgical procedure
Secondary endpoints Reduction of blood loss proportion of postoperative adverse events and negative tumor margins
Exploratory endpoints Surgical planning ease changes in surgical plan and surgeon satisfaction
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None