NCT06237621

Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Kent Imaging Inc · Industry
• Sex: All
• Age: 35 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is designed as a prospective observational study to assess the effectiveness of NIRS to accurately evaluate the degree of PAD, as compared to routine clinical assessment, during the PEMLE test protocol. This will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	SnapshotNIR imaging	SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment.

Timeline

• Start date: 2024-02-12
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2024-02-01
• Last updated: 2024-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study