Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-09 @ 6:45 PM
Study NCT ID:
NCT03294902
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2017-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
Sponsor:
Pedra Technology, PTE LTD
Organization:
Study Overview
Official Title:
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
Status:
COMPLETED
Status Verified Date:
2020-09
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:
IROAD
Brief Summary:
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact instrument console connected to a sensor that is pasted onto the patient's foot during perfusion assessment. Through skin contact, the device is able to monitor tissue perfusion at depths of up to 7.5mm. The monitor console contains opto-electronic instrumentation including coherent infrared light sources, photo detectors, and display/control electronics. The sensor comprises passive fiber-optic conduits, which transfer infrared light from the console to the patient, and relays scattered light from the patient back to the console. The intensity of light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I laser systems and comparable (or lower than) other commercially available devices such as laser Doppler systems. The sole point of contact with the patient is a layer of medical grade adhesive tape, which is used to paste the flat sensor onto intact skin.
Detailed Description:
None
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?: