NCT06237621

Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

Name: Clinical Trial NCT06237621
Creator: Kent Imaging Inc
Keywords: Peripheral Arterial Disease, SnapshotNIR imaging, device, clinical trial, United States of America

Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.

Kent Imaging Inc·ClinicalTrials.gov·device·Device trialRecruiting

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Study focus

Disease/Condition: Peripheral Arterial Disease
Drug/Device/Intervention: SnapshotNIR imaging
Study type: Observational
Intervention type: device

Sponsor & location

Primary sponsor: Kent Imaging Inc
Location: San Antonio, United States of America

Timeline & enrollment

Phase: N/A
Start date: Jan 01, 2024
End date: Jun 01, 2025
Enrollment: 150 participants

Primary outcome

Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD

Summary

The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments.

ICD-10 classifications

Peripheral vascular disease, unspecifiedOther peripheral vascular diseasesOther specified peripheral vascular diseasesPeripheral angiopathy in diseases classified elsewhereOther congenital malformations of peripheral vascular system

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06237621
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT06237621 through Pure Global AI's free database. This phase not specified trial is sponsored by Kent Imaging Inc and is currently Recruiting. The study focuses on Peripheral Arterial Disease. Target enrollment is 150 participants.

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