Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544135
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-08
Brief Title:
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Status:
NOT_YET_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:
TIC
Brief Summary:
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure
The main question this study aims to answer is
- Are temperature measurements from a forward looking infrared FLIR camera of the lower extremity useful in predicting outcome of revascularization procedures
The main question this study aims to answer is
- Are temperature measurements from a forward looking infrared FLIR camera of the lower extremity useful in predicting outcome of revascularization procedures
Detailed Description:
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure
Patients with lower extremity PAD will be seen in office pre-intervention Consent to participate in the TIC study will be acquired at this point Patients will be given a physical copy of their consent form at the time consent is obtained During this initial visit or subsequent pre-procedural office visit the smartphone-based thermal camera will be utilized to measure the temperature of the lower extremity foot ankle and leg at the plantar dorsal and lateral distributions Comorbidities and demographic factors will be documented from medical records at this time as well
Data will be gathered at a consistent location to minimize impact of room temperature on measurements
Patients will then undergo scheduled revascularization with the interventionist
Post-intervention pictures will be taken immediately after revascularization
Patients will then be seen again by the research team for follow-up thermal camera imaging 1 week post-intervention and weekly post intervention for at least 1 month but up to 6 months
Thermal measurements will be correlated with intra-op imaging and clinical outcomes in data analysis
Patients with lower extremity PAD will be seen in office pre-intervention Consent to participate in the TIC study will be acquired at this point Patients will be given a physical copy of their consent form at the time consent is obtained During this initial visit or subsequent pre-procedural office visit the smartphone-based thermal camera will be utilized to measure the temperature of the lower extremity foot ankle and leg at the plantar dorsal and lateral distributions Comorbidities and demographic factors will be documented from medical records at this time as well
Data will be gathered at a consistent location to minimize impact of room temperature on measurements
Patients will then undergo scheduled revascularization with the interventionist
Post-intervention pictures will be taken immediately after revascularization
Patients will then be seen again by the research team for follow-up thermal camera imaging 1 week post-intervention and weekly post intervention for at least 1 month but up to 6 months
Thermal measurements will be correlated with intra-op imaging and clinical outcomes in data analysis
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