Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT05334212
Status:
TERMINATED
Last Update Posted:
2023-02-13
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Surgical Theater's Patient Engagement
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Evaluating the Impact of Surgical Theater's Patient Engagement 360VR Platform on Spinal Surgery Patient Expectations and Experiences
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of support/funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISTPE
Brief Summary:
To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.
Detailed Description:
Surgical Theater is a company that has developed a platform which can be used to describe and explain spinal surgery to patient before they undergo the procedure. The platform specifically implements data from the patient's own MRI and CT scans, creating a 3d reconstruction that can be seen through a virtual reality lens. This technology was developed to help clarify any concerns patient's may have before surgery, and help them better appreciate what will occur in the OR.
Surgical theater has FDA clearance for patient interaction and engagement. Our study is to take surgical theater into our clinics and, after a patient is defined as a surgical candidate, use surgical theater to provide spatial learning and comprehension through modeling so they better understand their surgical plan. Only the SRP system will be used for this study (Surgical Planner).
The intervention is showing surgical theater to patients identified for surgery in clinic routinely. Surgical theater will be offered to all patients offered surgery. No other changes in practice will be done.
Surgical theater has FDA clearance for patient interaction and engagement. Our study is to take surgical theater into our clinics and, after a patient is defined as a surgical candidate, use surgical theater to provide spatial learning and comprehension through modeling so they better understand their surgical plan. Only the SRP system will be used for this study (Surgical Planner).
The intervention is showing surgical theater to patients identified for surgery in clinic routinely. Surgical theater will be offered to all patients offered surgery. No other changes in practice will be done.
Study Oversight
Has Oversight DMC:
False
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?: