Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-05 @ 8:23 AM
Study NCT ID:
NCT06544135
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Status:
RECRUITING
Status Verified Date:
2025-05
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:
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?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: