Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05732558
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2023-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
Sponsor:
R.A.W. - S.R.L.
Organization:
Study Overview
Official Title:
Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
Status:
COMPLETED
Status Verified Date:
2023-03
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 goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.
Detailed Description:
In this study results obtained in the prospective group will be compared with those obtained in the retrospective group.
Total N° of patients: 16
PROSPECTIVE GROUP (treated WITH the guidance of endosight):
N° of patients: 8
RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):
N° of patients: 8
Main objective of the study:
Reduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans.
N°of hospitals involved: 2.
Duration: maximum 6 months from the date of the first enrollment.
No follow-up is expected.
Total N° of patients: 16
PROSPECTIVE GROUP (treated WITH the guidance of endosight):
N° of patients: 8
RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):
N° of patients: 8
Main objective of the study:
Reduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans.
N°of hospitals involved: 2.
Duration: maximum 6 months from the date of the first enrollment.
No follow-up is expected.
Study Oversight
Has Oversight DMC:
False
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?: